Acc Nov2018.Pdf

STATE OF IOWA IOWA DENTAL BOARD

KIM REYNOLDS, GOVERNOR JILL STUECKER ADAM GREGG, LT. GOVERNOR EXECUTIVE DIRECTOR

ANESTHESIA CREDENTIALS COMMITTEE AGENDA NOVEMBER 1, 2018 12:00 P.M. *Updated 10/26/2018* Location: Iowa Dental Board, 400 SW 8th St., Suite D, Des Moines, Iowa. The public can also participate by telephone using the call-in information below:

1. Dial the following number to join the conference call: 1-866-685-1580 2. When promoted, enter the following conference code: 0009990326#

Members: Michael Davidson, D.D.S., Chair; Steven Clark, D.D.S.; John Frank, D.D.S.; Douglas Horton, D.D.S.; Gary Roth, D.D.S.; Kurt Westlund, D.D.S.; Jonathan DeJong, D.D.S.; Kaaren Vargas, D.D.S. (alternate)

I. CALL MEETING TO ORDER – ROLL CALL

II. COMMITTEE MINUTES a. July 19, 2018 – Teleconference

III. APPLICATION FOR GENERAL ANESTHESIA PERMIT

IV. APPLICATION FOR MODERATE SEDATION PERMIT a. Megumi Williamson, D.D.S. b. Zachary Stecklein, D.D.S.

V. OTHER BUSINESS a. For Review and Recommendation – Updated Draft of Proposed Rulemaking – IAC 650—Ch. 29, “Sedation and Nitrous Oxide Inhalation Analgesia” b. 2019 Meeting Dates

VI. OPPORTUNITY FOR PUBLIC COMMENT

400 SW 8th STREET, SUITE D, DES MOINES, IA 50309-4687 PHONE:515-281-5157 FAX:515-281-7969 http://www.dentalboard.iowa.gov

VII. ADJOURN

If you require the assistance of auxiliary aids or services to participate in or attend the meeting because of a disability, please call the Board office at 515/281-5157.

Please Note: At the discretion of the committee chair, agenda items may be taken out of order to accommodate scheduling requests of committee members, presenters or attendees or to facilitate meeting efficiency. STATE OF IOWA IOWA DENTAL BOARD

KIM REYNOLDS, GOVERNOR JILL STUECKER ADAM GREGG, LT. GOVERNOR EXECUTIVE DIRECTOR

ANESTHESIA CREDENTIALS COMMITTEE

MINUTES July 19, 2018 Conference Room 400 S.W. 8th St., Suite D Des Moines, Iowa

Committee Members July 19, 2018 Michael Davidson, D.D.S. Present Steven Clark, D.D.S. Present Jonathan DeJong, D.D.S. Present John Frank, D.D.S. Present Douglas Horton, D.D.S. Present Gary Roth, D.D.S. Present Kurt Westlund, D.D.S. Present Kaaren Vargas, D.D.S. (alternate) Absent

Staff Members Jill Stuecker, Christel Braness, Steve Garrison

I. CALL MEETING TO ORDER – JULY 19, 2018

Ms. Braness called the meeting of the Anesthesia Credentials Committee to order at 12:03 p.m. on Thursday, July 19, 2018. The meeting was held by electronic means in compliance with Iowa Code section 21.8. The purpose of the meeting was to review meeting minutes, applications for sedation permit, and other committee-related business.

Roll Call: Member Clark DeJong Frank Davidson Horton Roth Westlund Vargas Present x x x x x x Absent x x A quorum was establishedDRAFT with six (6) members present.

II. COMMITTEE MINUTES

. May 17, 2018 – Teleconference

400 SW 8th STREET, SUITE D, DES MOINES, IA 50309-4687 PHONE:515-281-5157 FAX:515-281-7969 http://www.dentalboard.iowa.gov

 MOVED by DAVIDSON, SECONDED by FRANK, to APPROVE the minutes as submitted. Motion APPROVED unanimously.

III. APPLICATION(S) FOR GENERAL ANESTHESIA PERMIT

. Gentry Hansen, D.D.S.

Ms. Braness provided an overview of the application.

 MOVED by DAVIDSON, SECONDED by DEJONG, to APPROVE the application as submitted. Motion APPROVED unanimously.

. Brandon M. Syme, D.D.S.

Ms. Braness provided an overview of the application.

 MOVED by DEJONG, SECONDED by CLARK, to APPROVE the application as submitted. Motion APPROVED unanimously.

IV. APPLICATION(S) FOR MODERATE SEDATION PERMIT

. Marian Antonious, D.D.S.

Ms. Braness provided an overview of the application.

 MOVED by CLARK, SECONDED by HORTON, to APPROVE the application as submitted. Motion APPROVED unanimously.

V. OTHER BUSINESS

. For Review and Discussion – Updated Draft of Proposed Rulemaking – IAC 650—Ch. 29, “Sedation and Nitrous Oxide Inhalation Analgesia” i. ADA Sedation Guidelines ii. Letter Requesting Information Regarding Sedation Guidelines in Other States and With National Organizations

Ms. Braness provided an update on the status of the proposed rulemaking.

Dr. Frank addressed the letter, which he has proposed. The intent would be to gather information related to deep sedationDRAFT and general anesthesia on the national level. Dr. Frank believed that this would be useful in moving forward on the rulemaking. Dr. Frank recommended that minimum standards for sedation training be required.

Anesthesia Credentials Committee – Subject to ACC Approval July 19, 2018 (Draft: 8/14/2018) 2

Dr. Horton reported that this issue was discussed at a meeting of the ASDA (American Society of Dental Anesthesiology) in Boston, MA. Many of the comments from that meeting were similar to those expressed by Dr. Frank.

 Dr. Westlund joined the meeting at 12:14 p.m.

Dr. Roth asked about the number of waivers that specifically requested exemptions pertaining to deep sedation and general anesthesia. Ms. Braness reported that 3-4 waivers had been received to date.

Dr. Davidson stated that at the previous Board meeting, the Board members appeared to be in favor of having a separate anesthesia provider when possible; though, not to the extent of prohibiting a single provider.

The committee continued to discuss the concerns related to the proposed changes. Dr. Horton was in favor of requiring some training in airway management. Dr. Frank stated that there were a number of concerns related to providing deep sedation in a dental office. As an example, Dr. Frank stated that patients occasionally get violent during recovery. An untrained dentist may not be prepared for that sort of outcome. Dr. Westlund agreed that there needed to be measures in place that would protect the public.

Ms. Stuecker reported that there would be a panel discussion related to these rules at the August 2018 Board meeting. Ms. Stuecker also referenced the letter that Dr. Frank had proposed. Ms. Stuecker asked if there was a consensus by the committee to send the letter.

Dr. Westlund was in favor of sending the letter; though, he recommended clarifying some of the language. For example: . What restrictions or requirements do states have in place concerning the delegation of sedation to another provider? . Must the delegation of sedation be lateral (e.g. moderate sedation permit holder could delegate moderate sedation)? . Could the delegation of sedation also be vertical (e.g. moderate sedation permit holder could delegate deep sedation)?

Dr. Roth indicated that he was in favor of using less restrictive language, and allowing permit holders to delegate one level higher. Dr. Frank asked if a moderate sedation course would be sufficient for the purposes of delegating the administration of deep sedation.

 MOVED by DAVIDSON, SECONDED by CLARK, to send the letter. Motion APPROVED unanimously. DRAFT Dr. Davidson addressed the proposed requirement for ACLS or PALS certification for dental auxiliary who monitor sedation services. Dr. Davidson was in favor of requiring this for deep sedation or general anesthesia; however, he believed that it may be unnecessary for moderate sedation.

Anesthesia Credentials Committee – Subject to ACC Approval July 19, 2018 (Draft: 8/14/2018) 3

Ms. Braness noted that any training, which would be required by rule would need to be training that could be obtained. It was not clear to Ms. Braness whether alternatives were available within existing programs. Dr. Horton, Dr. Westlund and Dr. Frank noted that groups such as the ASDA and AAOMS have programs specifically designed for auxiliary who assist in sedation. Ms. Braness stated that she would research these options further as an alternative to ACLS/PALS certification.

Dr. Thies agreed that ACLS/PALS certification may not be accessible to dental auxiliary, and was in favor of other training that would be better focused on the services auxiliary would be able to perform in emergencies.

OPPORTUNITY FOR PUBLIC COMMENT

There weren’t any comments received.

VI. ADJOURN

 MOVED by WESTLUND, SECONDED by DEJONG, to ADJOURN. Motion APPROVED unanimously.

The Anesthesia Credentials Committee adjourned its meeting at 12:45 p.m.

NEXT MEETING OF THE COMMITTEE

The next meeting of the Anesthesia Credentials Committee is scheduled for August 30, 2018. The meeting will be held at the Board office and by teleconference.

These minutes are respectfully submitted by Christel Braness, Program Planner 2, Iowa Dental Board. DRAFT

Anesthesia Credentials Committee – Subject to ACC Approval July 19, 2018 (Draft: 8/14/2018) 4

APPLICATION FOR MODERATE SEDATION PERTVTIT

IOWA DENTAL BOARI) 400 S.W. 8th Srreet, Suite D. Des Moines. lowa 50309-4687 Ph. (51 5) 281-5157 http://www.dentalboard.iowa.gov

'l'his lbrm must be completed and retumed to the lowa Dental Board. lnclude the non-rdundable applicaaion fee $500. Do not submit pa) ment in cash. Complete each question on the application. lfnot aoolicable. mark "N/A." Full Lcarl NrmG: (Lrsl. Flrrt, Mlddl.) W i tlia mso^ Mear r wti H *a. Olh.r N.mcs tlscd: (c.9, Mridcn Nrmr) Mequ-mi A ira llomc Addrcss: oM+ EasrbeoA A. City: County: Strt.: Zlgi t-ooa, C'rW .l r,ha 1oA AA 52245 lowr l,iccnrc ll: lssu. Dra.: Erparlaion Drt.: Typ. of Prrcllcc: FAC. LhIAq oA/x/zotg Dg/ / 2D2o Frtrtil+tt ord?*itP LOCATIONS IN IOWA WHERE MODERATE SEDATION"1 SERVICES WILL BE PROVIDED l.iP Oflicc Oflicc Addrcsr Cltv Phonc Codc llourJDrvs Tr,4t nv?,€*ry of hs . cdtelzotvA Q:4111- g:q 9ol Narrmn 2),7fuu', Aou City 52142 on- req-+o4r+ t^an-tlulrh(

BASIS FOR APPLICATION Chcck if D.tc(s) Typc of Tmlning Completcd coDDlctcd comolctcd:

A minimum of 60 hours instruction tlat meets ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Denul Studenrs. Ocrober 2016. fl v.' E tlo aoW (e.g. .4D.l-accredited residencv or continuing educotion program.) At4uA

Managemcnt ot'a minimum ol'20 patients. f,v"' DNo ttue 29W Formal training in ainvay management: flv"' ENo

Residency training. which included raining in pediatric xdation: E Yes EI no Residency training, which included training in medically-compmmised patiens: [tves E No fiine 1,f,|?r ACLS/PALS ceniflcation: (Dare of expiration: ) flv.' E No lAav eolt

Permit. i Approved by ACC: ACLS/PALS: Fees: For Oflicc Urc Only Issue Date: Licensc # lnspcction: Iraining: Ped,rMC Name of Applicant:

MODERATE SEDATION TRAINING INFORMATION Typc of Pmgrem;

fl Postgraduate residency I Continuing Education Program E Other Board-approved program, specify: llrmc ofTrrlnlns Proorrm: I Strect Address: City: Str t.: th3 tnivasiti*funr&avu.l g.utfr itatl c6 *?*50 ^$ ch,a.od Hill NC Type of Exptricnce;

Lcngth of Training: Dalcs Complctcd: bb r,r,ofifl^s -frntt t# 2OrB Numbar ol Prtlcnl Contrct Hours: Totrl Numbcr of Supcrvised Scdrtion Crscs: > Looo pves D No L Did you satisl'actorily complete the above training program? Svr:s D No 2. Did the cuniculum include training in physical evaluation? fives E No 3. Did the curriculum include tmining in lV sedation? Elyes D uo 4. Did the curriculum include training in ainvay management? [tvrs E No 5. Did the curriculum include training in monitoring? [tves E No 6. Did the curriculum include training in basic life suppon and emergency management? ElYes E ruo 7. Did the program include the clinical experience in managing compromised airways?

pves E No 8. Did the program include rescuing patients t'mm a deeper level of sedation than intended, including, but not limited to, intravascular or intraosseous access and reversal medicarions?

Eves E *o 9. Did the program provide training or experience in managing moderate sedation in pediatric patients?

Svus tr 10. Did the program provide training or experience in managing moderate sedation in medically- compromised patienls?

MODERATE SEDATION EXPERIENCE

E YES E NO I f. Do you have a license, permit or rcgisrration to perform modcrate sedation in any other state? lfyes. specify state(s) and permir numbers:

EYES E XO I Z. Do you consider yourself engaged in the use of moderare sedation in your prol'essional practice?

! ves El No | :. Have you ever had any patient mortality, or other incident, which resulted in the temporary or pennanent physical or mental injur,v requiring hospitalization of the patient during, or as a result ol, your use ofantianxiety premedication, nitrous oxide inhalation analgesia. moderate sedation or deep sedatiorVgeneral anesthesia? MODERATE SEDATION EXPERIENCE

DYES E *o 4. Do 1'ou plan to us: moderate scdation in pediatric patients? EvEs E No 5. Do y'ou plan to usc moderate sedation in mcdically-comprom ised (ASA 3-4) patients? Eves ENo 6. Do you plan to engage in enteral moderate sedation? flves E No 7. Do you plan to engage in parenteral moderate sedation'J Whet mrjor drugs rnd anc3thetic tcchnlqucs do you utlllzc or pl.n to utilizc in your usc of modemtc sGdrtlon? Provide details (lV. inhalation. etc.) and attach a separate sheet if necessarl'. IV s;rldion 2 fi\rfrDla.ffr 1e*tanvl

AUXILIARY PERSONNEL

A denlist administering moderate sedation in lowa musl documenl and cnsurc that all auxiliarv personn€l have ccnificaaion in basic lilb suppon (BLS) and are capablc of administering basic life suppon. Please list b€low the name(s), licens€i registration number, and BLS cenification status ol'all auxilian' oersonnel. Attached another sheet if necessan'. :irmc: Llccnsc/Rcgistntlon fl : CPR Ccrrillcrtion Drtc: CPR Ccrtificrrion Erpintlon CrroicUlE,WOft o"" lrt4Drir{rll'rmtst 'rc to* 2D51+ oO/ot/ t:ot+ o(o / aoR l{rmc: CPR C.]llritrlion Drlc: CPR Ccrlillcrrion llrpinlion Drtc: Ketb M.6carr{rct-6 WiB#ln^"u, t+{ ol/,;0t9 nl / lMo Nrmcl Liccn$/Rctillrrlion l: CPR Ccrllllcrllon Drlc: CPR Ccniticrlion Erpirrrioo M MW -n1+ot+w Drtct*1-4aqv$ Namc: Liccnsc/Rcgbtntion ll: CPR Ccrtifkrtion Drtc: CPR Crrtificrlion f, rpinllon Drlc:

Nrmc: L iccns./Rcflill rr I lon lt: CPR C?rliIlcrtio, Drtc: CPR Ccrtiflcrlion Erplrrlion Drac:

j\ r mc: LiccnsdRrgbtrrtioa l: CPR Ctrtificrtion Drlc: CPR Ccrllficrtion Erpintion Drac:

l\rmc: l-iccnrdRc8lrtrralon l: CPR Ccrlificrlion Drlc: CPR Ccrtiri.rllorl Erplrrlion Drl.:

frmc: Liccntc/RGtfulrrllon #: CPR. Ccrtificrtkrn Drlc: CPR C.nlri.rtion Erpirrlion Dra.:

l{rm.: l,iccnsc/Rcabrntion #: CPR Ccnificrtion Drlc: CPR C.riiti.rtlor Erpirrlion D.t.:

Nrmt: Liccnsc/Rcgirarllion il: CPR Ccrtificrlion Drtr: CPR Ccrlifi crtion Erpirrlion Det:: Name of Applicant: on

FACILITIES& EQUIPMENT

Each facility in which you perform modente sedation must be properly equipped. Cooy this oace and complete for each facilitv. You may apply for a waiver ofany olthese provisions. The Board may grant the waiver if it determines there is a reasonable basis for the waiver. ls your d.otr! omce propcrly melntrincd end cquippcd with thc following?

Svrs E No l. An operating mom large enough to adequately accommodate the patient on a table or in an operating chair and permit an operating team consisting ofat least two individuals ro move frcely aboul the patient?

Eves E uo 2. An opcrating table or chair that permis the patient to be positioned so the operating team can maintain the air*ay, quickly alter the patient position in an emergency. and provide a firm platform for the management of cardiopulmonary resuscitation?

Eves E ruo 3. A lighting system that is adequate to permit evalualion ofthe patient's skin and mucosal color and a backup lighting system that is battery powercd and ofsuflicient intensity to permit completion ofany operation underway at the time ofgeneral power failurc?

fives E ruo 4. Suclion equipment that permis aspiration of the oral and pharyngeal cavities and a backup suction device?

$vns E ruo 5. An oxygen delivery system with adequate full face masks and appropriate connecton that is capable ofdelivering oxygen to rhe patient under positive pressure, together with an adequate backup system? fi ves E r.lo 6. A recovery area that has available oxygen. adequate lighting, suction, and electrical outlets? (The recovery area can be the operating room.)

E! yrs E No 7, Is the patient able to be observed by a member of the staffat all times during the recovery period? Elves E No t. Anesthesia or analgesia systems coded to prevent accidental administration of the wmng gas and equipped with a fail-sal'e mechanism? flves D No 9. EKC monitor? S ves El no 10. Laryngoscope and blades? flves O No I l. Endotracheal tubes? flves EI uo 12. Magill forceps? pvrs E uo 13. Oral airways? flves E No 14. Stethoscope? Evas El No 15. Blood pressure monitoring device? 6lves E No 16. Pulsc oximeler? fi ves E r'ro 17. Emergency drugs that are not expired? fives O No I 8. A defibrillator (an aulomated defibrillator is recommended)? pves E r.ro 19. Capnography machine? Bves E No 20. Pretracheal or precordial stethoscope? flves E No 21. Do you employ volatile liquid anesthelics and a vaporizer (i.e. Halothane, Enflurane, lsollurane)? Elves E r.ro 22. How many nitmus oxide inhalation analgesia units are in your facility? _

r', r'f r l\;), ,. rir., ) l/-,' ili' ( l,lt)i. I .', ri) Name of Applicant:

DEFINITIONS lmoortant! Read these definitions before comolctine lhe followinq questions.

'Ability to prEctice dentistry with reasonable skill and srfcty'means ALL of the following: l. The cognitive capacity to make appropriate clinical diagnosis, exercise reasoned clinical judgments, and to learn and keep abrcast of clinical developments; 2. The ability to communicate clinical j udgments and information to patients and other health care providers; and 3. The capability to perform clinical tasks such as dental examinations and dental surgical procedures.

'Medical condition' means any physiological, mental, or psychological condition. impairment, or disorder, including drug addiction and alcoholism.

*Chemica! subslances' means alcohol, legal and illegal drugs, or medications, including those taken punuant to a valid prescription for legitimate medical purposes and in accordance with the prescriber's direction, as well as those used illegally.

"Currently'does not mean on the day of. or even in weeks or months preceding the completion of this application. Ralher, it means recently enough so that the use of chemical substances or medical conditions may have an ongoing impact on the ability to function and practice, or has adversely affected the ability to function and practice within the past two (2) years.

*lmproper use of drugs or other chemical substrnc€s' means ANY of the following: l. The use of any controlled drug, legend drug, or other chemical substance for any purpose other than as directed by a licensed health care practitioner; and 2. The use ofany substance, including but not limited to, petroleum products, adhesive products, nitrous oxide, and other chemical substances for mood enhancement. *lllcgal use ofdrugs or other chemicsl substlnces" means the manufacturc, possession, distribution, or use ofany drug or chemical substance prohibited by law.

PI'RSONAI.& CONFID

lfyou answer "l'es" lo any questions l-l I below, attach a writlen. signed explanation. Attach additional pages, ifneeded.

E YgS El *O I t. no yo, currently have a medical condition that in any way impairs or limits your ability ro pracrice dentistry with reasonable skill and safery?

! VeS E UO | 2. erc you currently engaged in the illegal or improper use ofdrugs or other chemical substances?

E YeS E ruo I l. noyou currently usc alcohol. drugs, orother chemical substances thar would in any way impairorlimir your abilhy to practice dentistrl with rrasonable skill and safety?

E Vp.s tr Nq -. | +. lf VeS to any ofrhe above. are you receiving ongoing treatment or paflicipating in a monitoring program N/A I thal rcduces or eliminates the limilations or impairments caused by either your medical condition or use of alcohol, drugs. or other chemical substances? Name of Applicant:

lfyou answer "yes" to any questions l-l I below, attach a writlen, signed explanation. Atlach additional pages. ifneeded.

E ves E[ uo 5. Haveyou ever been requested to rcpeat a ponion ofany professional training program/school?

E vrs EIl.ro 6. Have you ever rcceived a waming, reprimand. or been placed on probation during a professional training program,'school?

! ves ENo 7. Have you ever voluntarily surrendered a license or permit issued to you by any profcssional licensing agency?

E vas ENo 7a. lfyes, was a license disciplinary action pending against you, or werc you under investigation by a N/A licensing agency at thu time the voluntary surrender of license was tendercd?

E ves E r.ro 8. eside from ordinary initial rcquirements of proctorship, have your clinical activities ever been limited, suspended, revoked. not renewed. voluntarily rclinquished. or subjeo to other disciplinary, or probationary conditions?

Elvrs E*o 9. Has any jurisdiction ofthe United Slates or other nation ever limited, resricted. wamed, censured, placed on probation, suspended, or revoked a license or permit you held?

E ves I 0. Have you ever been notified of any charges filed against you by a licensing or disciplinary, agcncy F*o ofany jurisdiction ofthe U.S. or olher nation?

Eves E No I I . Have you ever been denied a Drug Enforcement Administralion (DEA) or state controlled substance registration cenificate or has your controlled substance registration ever been placed on probation, suspended, voluntarily surrendered or revoked?

YESE lNotr 12. Do you [nd.rtlrtrd thtt lf r pcrolt k gnulcd by thb boerd, lt wlll bc b$Gd ln p.rt on thc lruth ol lhc !t lcmcDts conlrhcd hcrtln, whlch, ll frlsc, ury 3ubJlct you to criDlnr! pros.cutlotr rnd ncvoc.ffon of thc llcaorc?

( ll rl)tr,r -,! Name of Applicant: qno6o6

AFFIDAVIT OF APPLICANT l, the below named applicant, hereby declare under penalty of perjury that I am the peron described and identified in this application and that my answers and all statements made by me on this application and accompanying anachments are true and correct. Should I fumish any false information, or have substantial omission, I hereby agree that such act shallconstitute cause for denial, suspension, or revocation ofmy license or permit to provide moderate sedation. I also declare that ifl did not personally complete the foregoing application that I have lully read and confirmed each question and accompanying answer, and take lull responsibility for all answers contained in this application.

I understand thal I have no legal aulhority to administer moderate sedation until a permit has been granted. I understand that my facility is subject to an on-site evaluation prior to the issuance ofa permit and by submining an application for a moderate sedation permit, I hereby consent to such an evaluation. ln addition, I understand that I may be subject to a professional evalualion as part ofthe application process. The professional evaluation shall be conducted by the Anesthesia Credentials Comminee and include, al a minimum, evaluation of my knowledge of case management and airway management.

I cerrifr that I am trained and capable ofadministering Advanced Cardiac Life Support and that I employ sufficient auxiliary personnel to assisl in monitoring a patient under moderale sedation. Such personnel are trained in and capable of monitoring vital signs, assisting in emergency procedures, and administering basic life support. I understand that a dentist performing a procedure for which moderate sedation is being employed shall not administer the pharmacologic agents and monitor fte patient withoul the presence and assistance ofat least one qualified auxiliary personnel.

I am aware thal pursuant to lowa Administrative Code 650-29.9(153) I must report any adverse occurences related to the use of moderate sedation. I also undersland that if moderate sedation results in a general anesthetic state, the rules for deep sedation/general anesthesia apply.

I hereby authorize the release ofany and all information and records the Board shall deem pertinent to the evaluation ofthis application, and shall supply to the Board such rccords and information as requested for evaluation ofmy qualifications for a pe rmit to administer moderate sedation in the state of lowa.

I understand that based on evaluation ofcredentials, facilities, equipmen! pcrsonnel, and procedures, the Bodrd may place restrictions on the p€rmit.

I further state that I have read the rules related 10 the use of moderate sedation, deep sedation/general anesthesia and nitrous oxide inhalation analgesia, as described in 650 lowa Administralive Code Chapter 29. I hereby agree to abide by the laws and rules pertaining to the practice ofdentistry and moderale sedation in the state of lowa.

S i gn ature O rr' oarc ", r)U+r-Ogr, OO /aQ/ 2ot6 "*,,,{rt4,I ta^r^^i

:'i't '.'lr, l.l :Li'l ,lrrl,l,,, , Name of Applicant:

APPLTCATION ACKNOWLEDG EMENTS Et ress Pursuant to lowa Administrative Code 650-Chapter 15, application fees are non-refundable. lll ruooen.lrE SEDATToN AND/oR cENERAL ANESTHESIA Denlists licensed in lhe state oflowa cannot administer deep sedation/general anesthesia or moderate sedation in the practice of dentistry until an active permit has been issued to you. For additional information. please refer to the Board's rules at lowa Administrative Code 650-Chapter 29.

IXI runlrc REcoRDS All or part olthe information provided on the application form may be considered a public record under lowa Code chapter 22 and lowa Administrative Code 650-Chapter 6. lnformation on misconduct and examination results is not subject to disclosure. Criminal history may be subject to disclosure. M rppLrcrrroxs s 4bfit@ ofilirw Permits are issued administratively following review and approval of a completed application and all required documentation by the Anesthesia Credentials Comminee. Based on its evalualion of credenlials. facilities, equipment. personnel. and procedures, restrictions may be placed on the p€rmit.

Applications are valid for only I 80 days from the date of receipt. I f the application has not been completed within I 80 days, a new application and fee will have to be submined if you wish to obtain a license in lowa. p lcmrrluscrnrtrtclrtox + Sula'ael Oalir-a

I hereby declare that I possess a valid certificate from a nationally-recognized course in ACLS/PALS that includes a "hands- on" clinical componenl. I acknowledge that proof of certi fication will be maintained and made available to the Board upon request.

I hereby declare thst I ecknowledge the sistemenls above concerning fees, moderate sedstaon end/or general rresthesiar public records, applications, and ACIS/PALS certificgtion. CERTIFTCATION OF MODERATE SEDATION TR.AINING - r,\l

tBtr[tdoEs - For.rvld thb ,oru to O! dlrcctor of your tod.rrta radrtbD tr.lra4 co.l1a. ,Mc6u-wri ftta. tDitlia,rrreon ,/ Meqruni lq8* Urty/lilllc:= Email ArHrcss: Iorra Olw . 14 hn<{*mi - urilliameon@ rrbha . eau l o ootln . pcnu to t ltrudlr modcttr. rc(Ein in loli.l, rhc lorn Dafd Bcd rc+rircs ufntryrqrro or uhct fcmd rriniq progruupotrcd'ty rt. Brd ii. , tcro* ],'P[y_ry*d +ri*,r lc** lirorde m fq ?y]?fr.rlrioo. E r$tc a dt.rlris, dircdl, b tu tot,a DsrC Bcd d ltE et.r &@c. APPUCmTS Stgntnlt: .\ | Datc: : *lAenrr.^ l+),',...",-.nr I oa /el leo|,,, Fr TO BE COI}IPLETED BY MODERATE SEDATION TNAINING DNECTOR Namc of Modctatc Scdation Tninirypnognm-- Udlvacs'rrt or nloarn'C*&it 9cA6.- OF A€r.Jn i4) sr-t -r7 3+ lll .BA*,E". tl^u.- . Depr. pE\i.rll,N1oto6l, Cl-SrtH;l , NC L1571 nEil Addrrss: .DP. *^r7oNio {. M6jag71 a nfon io tqo ra+f-,-e- u vtc . e4, ct Try of Tmlning ProSra,rn: - EJ lccrrdlrcd po.q3rrdurtc rciuGocy profrrr (ADA, AMA, AOA) / pi! tfc rcsiacncy prognm includc training ' in thc modcratc scdation of podiarric paricna? y6 d No D . Did rhc residenc, ;d# #ffi il;ffi il ff ffiffi ffiiil;lffiil,irHf#.li'*,.ilr'".. / *o tr I Coldnrl4 cdtrttloo coune ' Did the cooflc include trainiry ln thc usc of more than onc drug in modcatc rodatioa? y6 E No E If yca. pl6c Iisr &ugs irrcludcd in rhc uriniq: Fmm (MoYr):' - To (Molfr): 'Julv Zot, Juta- ZoH Elves EI No l. Did thc rpplkant s.ti3frcrorily complerc rhe rbove trainiry prognm?

dv* E xo 2. Did rhc pmgrun lncludc a lcs sixV (60) houn of didrric uainiry in pain md Ulxicry? No pm3rrn flvrs E 3. Did thc comply with thc aui&lincs of thc ADA Guidclircc for T6hin8 plin co.ruol and Scdarhn b Ehili$ ud Dqlhl StrdcnEt O.robcr 2016?

drm E No 4. Did the prqnm includc thc mura3ancn of s minimum of 20 pciaro? r.ro progrm dves E 5. Did thc includc tdni4 tlrar addrcrscs how to rcsc.c parlars frorn a deepcr lc*er of scduion thrn intcnd. including. bur nor limitcd lo, inravasculrr or intruscous'o.cs ua rcrcrsal medicrrions?

d"r. E xo 6. Did thc pqrm incldc clinicet expcricncc in mana3inj comprorniscd ainrays? (tf m. prersc provi& a dctrilcd cxpltreion.)

EYEs dwo 7' Did tr rppticant acr reccivc e rtrniry, reprirnend, a uns the applicant plecod m probrtlon dring thc uainlng p.ojnm? (tf ycs, ptclsc erphin.)

Eves dno t. vrs drc pplkrnr cvct rtq,cocd o cpear a portion of $c rnlnrn3 progrun? (rf ycs, pleasc cxpldn).

I llrllor [f ccill] L.r G. .bory]..!.d rppf,cul her dcuodnttd colparrrry b drlrttcrlr6 oodr111j 5;drtlo. r1d rln y [aD.tr.ari. *' !/lt / znlg r!l!1d+ p.rm't r, , \F4 r(),] Apptir,rtK)n - IAC b5{)-Chepler .lg U|'C rtcd 4l l5i ?013 Moderate Sedation Permit (Online) Application Summary Name: Zachary Stecklein, D.D.S.

Training Provider: Conscious Sedation Consulting (CE Course)

Facility Location: 120 E Fayette St., Manchester, Iowa This is a new location, which will require inspection.

Ineligible to sedate pediatric or medically-compromised patients.

License Detail Report

First Name: Zachary Last Name: Stecklein October 24, 2018 2:05 pm

Balance

License Basic Information License Type ANES-Moderate Sedation License Number Status Internet Wait Orginal Issue Date Balance $0.00

Facility Equipment

Operating room accommodates patient and 3 staff? Yes Operating table or chair sufficient to maintain airway and Yes render emergency aid? Lighting is sufficient to evaluate patient and has appropriate Yes battery backup? Suction equipment permits aspiration of oral / pharyngeal Yes cavities & a backup? Oxygen delivery system with adequate full face masks & Yes adequate backup? A recovery area that has oxygen, adequate lighting, suction, Yes & electric outlets? Is patient able to be observed by staff at all times during Yes recovery? Anesthesia / analgesia systems coded to prevent incorrect Yes administration? EKG Monitor? Yes Laryngoscope and blades? Yes Endotracheal tubes? Yes Magill forceps? Yes Oral airways? Yes Stethoscope Yes Blood pressure monitoring device? Yes A pulse oximeter? Yes Emergency drugs that are not expired? Yes A defibrillator (an automated defibrillator is recommended)? Yes Do you employ volatile liquid anesthetics and a vaporizer? No Number of nitrous oxide inhalation analgesia units in facility? 3

Facility Information

Joining previously inspected facility? No Equipment or exemption details Provide sedation at more than 1 facility? No Have the equipment requirements listed above been met? Yes Equipment exemptions? No License Detail Report

First Name: Zachary Last Name: Stecklein October 24, 2018 2:05 pm

Balance Final Acknowledgements Application Signature Yes Application Signature Date Oct 24, 2018 14:05:31 ACLS/PALS Certification Acknowledgement Yes ACLS/PALS Expiration (mm/yyyy) 10/2020

Initial Acknowledgements

Sedation / LA Permit Acknowledgement Yes Public Record Acknowledgement Yes Non-Refundable App Fee Acknowledgement Yes App Valid 180 Days Acknowledgement Yes

MS Restrictions

Authorized to sedate pediatric patients? No Authorized to sedate ASA 3 or 4 patients? No

Other State Licenses

Permitted In Other States? No State Permit Number Date Verified State 2 Permit Number 2 Date Verified 2 State 3 Permit Number 3 Date Verified 3

Peer Evaluation

Peer evaluation conducted? No If no, is one required? Date of peer evaluation

Printing

Number of Extra Certificates ($25 ea.) 1 Number of Extra Renewal Cards ($25 ea.) 1

Renewal Period Option

Joint New / Renewal Qualified No Joint New / Renewal Accepted No

Sedation Experience

Any patient mortality or other incident? No License Detail Report

First Name: Zachary Last Name: Stecklein October 24, 2018 2:05 pm

Balance Details of incident Use enteral moderate sedation? Yes Use parenteral moderate sedation? Yes

Sedation Training Mod Sedation training program 60 hrs and 20 patients? Yes Airway management training? Yes Airway Training Date Oct 13, 2018 ACLS Certified? Yes ADA accredited residency program? No Specialty 1 Post Graduate Training Type 1 Post Graduate Training Institution 1 Institution 1 City & State Post Graduate Training 1 Start Date Post Graduate Training 1 End Date Continuing Education Course Yes Continuing Education Course Location Arvada, Colorado Continuing Education Course Date Completed Oct 21, 2018 Pediatric Training? No Pediatric Training Location Pediatric Training Date Med. Comp. Training? Yes Med. Comp. Training Location Aurora, Colorado Med. Comp. Training Date Oct 12, 2018 Marriage/Divorce Decree Submission Method?

Chronology

Out of State License Information State/Country Active License No. Date Issued License Type How Obtained

Question List and Details

Do you currently have a medical condition that in any way impairs or No limits your ability to practice dentistry with reasonable skill and safety? Are you currently engaged in the illegal or improper use of drugs or No other chemical substances? Do you currently use alcohol, drugs, or other chemical substances No that would in any way impair or limit your ability to practice dentistry with reasonable skill and safety? Are you receiving ongoing treatment or participating in a monitoring No program that reduces or eliminates the limitations or impairments caused by either your medical conditions or use of alcohol, drugs, or License Detail Report

First Name: Zachary Last Name: Stecklein October 24, 2018 2:05 pm

Balance other chemical substances? Have you ever been requested to repeat a portion of any No professional training program/school? Have you ever received a warning, reprimand, or placed on No probation or disciplined during a professional training program/school? Have you ever voluntarily surrendered a license issued to you by No any professional licensing agency? Was a license disciplinary action pending against you, or were you No under investigation by a licensing agency at the time a voluntary surrender of license was tendered? Aside from ordinary initial requirements of proctorship, have your No clinical activities ever been limited, suspended, revoked, not renewed, voluntarily relinquished, or subject to other disciplinary or probationary conditions? Has any jurisdiction of the United States or other nation ever No limited, restricted, warned, censured, placed on probation, suspended, or revoked a license you held? Have you ever been notified of any charges filed against you by a No licensing or disciplinary agency of any jurisdiction of the U.S. or other nation? Have you ever been denied a Drug Enforcement Administration No (DEA) or state controlled substance registration certificate or has your controlled substance registration ever been placed on probation, suspended, voluntarily suspended, or revoked?

Attachments

IBDE Mod Sed Training Cert Zach 001.jpg

Dental Board [650] Ch. 29, p. 1

DENTAL BOARD [650]

Notice of Intended Action The Dental Board hereby proposes to rescind Chapter 29, “Sedation and Nitrous Oxide Inhalation Analgesia” and replace with a new Chapter 29, “Sedation and Nitrous Oxide” Iowa Administrative Code 650.

Legal Authority for Rule Making

This rule making is proposed under the authority provided in Iowa Code section 147.76 and 153.33.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code sections 153.33, and 153.33B.

Purpose and Summary

The primary purpose of these amendments is to update the requirements for providing sedation and nitrous oxide inhalation analgesia in dental offices. The amendments have been drafted based on updated recommendations and input from interested parties.

These amendments would update requirements for providing moderate sedation, deep sedation and general anesthesia in dental offices. These amendments specify the conditions under which the administration of the sedation services may be delegated to another health care provider, such as an anesthesiologist or nurse anesthetist.

These amendments clarify that training in the use of nitrous oxide when enrolled in an accredited school of dentistry or dental hygiene is approved for the purposes of these rules. These amendments also clarify what a dental assistant is allowed and/or required to do while monitoring the administration of nitrous oxide.

These amendments establish a requirement for training in the monitoring of patients under moderate sedation, deep sedation, or general anesthesia. Due to the increased risk of these levels of sedation, the training could focus on additional training in observation of a patient under sedation, and prepare them for recognizing signs of an adverse reaction or occurrence.

These amendments would establish a prohibition the use of drugs intended for deeper levels of sedation from being employed for the purposes of moderate sedation. These amendments clarify the facilities and locations subject to inspection and the equipment required to maintained at each facility where moderate sedation, deep sedation and/or general anesthesia is performed. DRAFT These amendments update terminology to be more specific and to make clearer the requirements for providing sedation or nitrous oxide inhalation analgesia. These amendments also reorder some of the rules for clearer understanding and reference.

Dental Board [650] Ch. 29, p. 2

Fiscal Impact

This rule making has no fiscal impact to the state of Iowa.

Jobs Impact

After analysis and review of this rule making, there is no impact on jobs.

Waivers

The proposed amendments are subject to waiver or variance pursuant to 650-chapter 7.

Public Comment

Any interested person may submit written comments on this proposed rulemaking. Written comments in response to this rule making must be received by the Board no later than 4:30 p.m. on XXX. Comments should be directed to:

Steve Garrison, Program Officer Iowa Dental Board 400 S.W. Eighth Street, Suite D Des Moines, Iowa 50309 Email: [email protected] Fax: 515-281-7969

Public Hearing

No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)”b,” an oral presentation regarding this rule may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members.

Review by the Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee’s meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6). DRAFT

The following rule-making actions are proposed:

Dental Board [650] Ch. 29, p. 3

CHAPTER 29

SEDATION AND NITROUS OXIDE INHALATION ANALGESIA

[Prior to 5/18/88, Dental Examiners, Board of[320]]

650—29.1(153) Definitions. For the purpose of these rules, relative to the administration of deep sedation/general anesthesia, moderate sedation, minimal sedation, and nitrous oxide inhalation analgesia by licensed dentists, the following definitions shall apply:

“Antianxiety premedication” means minimal sedation. A dentist providing minimal sedation must meet the requirements of rule 650— 29. 3 (153).

“ASA” refers to the American Society of Anesthesiologists Patient Physical Status Classification System.

Category 1 means normal healthy patients, and category 2 means patients with mild systemic disease. Category

3 means patients with moderate systemic disease, and category 4 means patients with severe systemic disease that is a constant threat to life.

“Board” means the Iowa dental board established in Iowa Code section 147.14(1) “d.”

“Capnography” means the monitoring of the concentration of exhaled carbon dioxide in order to assess physiologic status or determine the adequacy of ventilation during anesthesia.

“Committee” or “ACC” means the anesthesia credentials committee of the board.

“Conscious sedation” means moderate sedation.

“Deep sedation/general anesthesia” is a controlled state of unconsciousness, produced by a pharmacologic agent, accompanied by a partial or complete loss of protective reflexes, including inability to independently maintain an airway and respond purposefully to physical stimulation or verbal command.

“Delegation of deep sedation/general anesthesia or moderate sedation” means the delegation of moderate sedation or deep sedation/generalDRAFT anesthesia in a dental facility by a sedation permit holder to sedation provider as permitted by state or federal law. Eligible sedation providers include another sedation permit holder, an anesthesiologist currently licensed by the Iowa Board of Medicine or a certified registered nurse anesthetist (CRNA) currently licensed by the Iowa Board of Nursing.

Dental Board [650] Ch. 29, p. 4

“Facility” means a dental facility office, clinic, dental school, or other location where sedation is used.

“Hospitalization” means in-patient treatment at a hospital or clinic. Out-patient treatment at an emergency room or clinic is not considered to be hospitalization for the purposes of reporting adverse occurrences.

“Maximum recommended dose (MRD)” means the maximum FDA-recommended dose of a drug as printed in FDA-approved labeling for unmonitored home use.

“Minimal sedation” means a minimally depressed level of consciousness, produced by a pharmacological method, that retains the patient’s ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected. The term “minimal sedation” also means “antianxiety premedication” or “anxiolysis.” A dentist providing minimal sedation shall meet the requirements of rule 650— 29. 3 (153).

“Moderate sedation” means a drug-induced depression of consciousness, either by enteral or parenteral means, during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Prior to January 1, 2010, moderate sedation was referred to as conscious sedation.

“Monitoring nitrous oxide inhalation analgesia” means continually observing the patient receiving nitrous oxide and recognizing and notifying the dentist of any adverse reactions or complications.

“Nitrous oxide inhalation analgesia” refers to the administration by inhalation of a combination of nitrous oxide and oxygen producing an altered level of consciousness that retains the patient’s ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command.

“Pediatric” means patients aged 12 or under.

[ARC 8614B, IAB 3/10/10, effectiveDRAFT 4/14/10; ARC 1194C, IAB 11/27/13, effective 11/4/13; ARC 3491C, IAB 12/6/17, effective 1/10/18] 650—29.2(153) Nitrous oxide inhalation analgesia.

29.2(1) A dentist may use nitrous oxide inhalation analgesia sedation on an outpatient basis for dental

Dental Board [650] Ch. 29, p. 5

patients provided the dentist:

a. Has completed training while a student in an accredited school of dentistry; or

b. Has completed another board-approved course of training, and

c. Has adequate equipment with fail-safe features and minimum oxygen flow which meets FDA standards.

d. Has routine inspection, calibration, and maintenance on equipment performed every two years and maintains documentation of such, and provides documentation to the board upon request.

e. Ensures the patient is continually monitored by qualified personnel while receiving nitrous oxide inhalation analgesia.

29.2(2) A dentist utilizing nitrous oxide inhalation analgesia shall be trained and capable of administering basic life support, as demonstrated by current certification in a nationally recognized course in cardiopulmonary resuscitation.

29.2(2) A licensed dentist who has been utilizing nitrous oxide inhalation analgesia in a dental facility office in a competent manner for the 12-month period preceding July 9, 1986, but has not had the benefit of formal training outlined in paragraph 29.2(1) “a” or 29.2(1)“b,” may continue the use provided the dentist fulfills the requirements of paragraphs 29.2(1) “c” and “d” and subrule 29.2(2).

29.2(3) A dental hygienist may administer nitrous oxide inhalation analgesia provided the administration of nitrous oxide inhalation analgesia has been delegated by a dentist, and the hygienist meets the following qualifications:

a. Has completed training while a student in an accredited school of dental hygiene; or

b. Has completed another board-approved course of training. 29.2(4) A dentistDRAFT who delegates the administration of nitrous oxide inhalation analgesia in accordance with 29.2(3) shall provide direct supervision and establish a written office protocol for taking vital signs, adjusting anesthetic concentrations, and addressing emergency situations that may arise.

29.2(5) A dental hygienist or registered dental assistant may monitor a patient under nitrous oxide

Dental Board [650] Ch. 29, p. 6

inhalation analgesia provided all of the following requirements are met:

a. The hygienist or registered dental assistant has completed a board-approved course of training or has received equivalent training while a student in an accredited school of dental hygiene or dental assisting;

b. The task has been delegated by a dentist and is performed under the direct supervision of a dentist;

c. Any adverse reactions are reported to the supervising dentist immediately; and

d. The dentist dismisses the patient following completion of the procedure.

29.2(6) Aregistered dental assistant who monitors a patient under nitrous oxide inhalation analgesia is prohibited from inducing, adjusting the levels of, or deducing nitrous oxide. After the dentist has induced a patient and established the maintenance level, a dental assistant may monitor the administration of the nitrous oxide.

A dental assistant may make adjustments, which decrease the nitrous oxide concentration during the administration, or turning off oxygen delivery at the completion of the dental procedure.

29.2(7) If the dentist intends to achieve a state of moderate sedation from the administration of nitrous oxide inhalation analgesia, the rules for moderate sedation apply.

[ARC 8369B, IAB 12/16/09, effective 1/20/10; ARC 8614B, IAB 3/10/10, effective 4/14/10]

650—29.3(153) Definition of minimal sedation.

29.3(1) The term “minimal sedation” also means “antianxiety premedication” or “anxiolysis.”

29.3(2) If a dentist intends to achieve achieves a state of moderate sedation from the administration of minimal sedation, the rules for moderate sedation shall apply.

29.3(3) A dentist utilizing minimal sedation and the dentist’s auxiliary personnel shall be trained in and capable of administering basic life support.

29.3(3) Minimal sedation for adults.

a. Minimal sedation for adults is limited to a dentist’s prescribing or administering a single enteral drug that is no more thanDRAFT 1.0 times the maximum recommended dose (MRD) of a drug that can be prescribed for unmonitored home use. A single supplemental dose of the same drug may be administered, provided the supplemental dose is no more than one-half of the initial dose and the dentist does not administer the

Dental Board [650] Ch. 29, p. 7

supplemental dose until the dentist has determined the clinical half-life of the initial dose has passed.

b. The total aggregate dose shall not exceed 1.5 times the MRD on the day of treatment.

c. For adult patients, a dentist may also utilize nitrous oxide inhalation analgesia in combination with a single enteral drug.

d. Combining two or more enteral drugs, excluding nitrous oxide, prescribing or administering drugs that are not recommended for unmonitored home use, or administering any intravenous drug constitutes moderate sedation and requires that the dentist must hold a moderate sedation permit.

29.3(4) Minimal sedation for ASA category 3 or 4 patients or pediatric patients.

a. Minimal sedation for ASA category 3 or 4 patients or pediatric patients is limited to a dentist’s prescribing or administering a single dose of a single enteral drug that can be prescribed for unmonitored home use and that is no more than 1.0 times the maximum recommended dose.

b. A dentist may administer nitrous oxide inhalation analgesia for minimal sedation of ASA category

3 or 4 patients or pediatric patients provided the concentration does not exceed 50 percent and is not used in combination with any other drug.

c. The use of one or more enteral drugs in combination with nitrous oxide, the use of more than a single enteral drug, or the administration of any intravenous drug in ASA category 3 or 4 patients or pediatric patients constitutes moderate sedation and requires that the dentist must hold a moderate sedation permit.

29.3(5) A dentist providing minimal sedation shall not bill for non-IV conscious or moderate sedation.

29.3(6) A dentist shall ensure that any advertisements related to the availability of antianxiety premedication, anxiolysis, or minimal sedation clearly reflect the level of sedation provided and are not misleading.

[ARC 8614B, IAB 3/10/10, effective 4/14/10] 650—29.4(153) Prohibitions.DRAFT 29.4(1) Deep sedation/general anesthesia. Dentists licensed in this state shall not administer or delegate the administration of deep sedation/general anesthesia in the practice of dentistry until they have obtained a

Dental Board [650] Ch. 29, p. 8

general anesthesia permit from this office. a permit. Dentists shall only administer or delegate the administration of deep sedation/general anesthesia in a facility that has successfully passed inspection as required by the provisions of this chapter.

29.4(2) Moderate sedation. Dentists licensed in this state shall not administer or delegate the administration of moderate sedation in the practice of dentistry until they have obtained a moderate sedation or general anesthesia permit from this board . Dentists shall only administer or delegate the administration of moderate sedation in a facility that has successfully passed inspection as required by the provisions of this chapter.

29.4(3) Pharmacologic agents. Sedation permit holders shall only use pharmacologic agents (Dilaudid,

Ketamine, Propofol) suitable for the intended level of sedation. Pharmacologic agents, which are manufactured for the purpose of deep sedation/general anesthesia shall only be used for that purpose.

29.4(4) Nitrous oxide inhalation analgesia. Dentists licensed in this state shall not administer nitrous oxide inhalation analgesia in the practice of dentistry until they have complied with the provisions of rule

650— 29. 2(153).

29.4(5) Antianxiety premedication. Dentists licensed in this state shall not administer antianxiety premedication in the practice of dentistry until they have complied with the provisions of rule 650— 29. 3 (153).

29.4(6) Delegation of dental services to auxiliary during sedation . A dentist utilizing or delegating the administration of moderate sedation or deep sedation/general anesthesia may only delegate services to be performed by other licensees or registrants provided the dentist prescribing those services is present in the treatment room while DRAFTthe patient is under moderate sedation or deep sedation/general anesthesia.

Dental Board [650] Ch. 29, p. 9

650—29.5(153) Definition of moderate sedation.

29.5(1) The term “moderate sedation” also means “conscious sedation.”

29.5(2) If moderate sedation is achieved in a patient, the dentist must hold an active sedation permit and comply with all requirements for administering moderate sedation in a dental facility as established in this chapter.

29.5(3) The following shall constitute moderate sedation:

a. The prescription or administration of a single does of a single enteral drug in excess of 1.5 MRD on the day of treatment;

b. The combination of more than one enteral drug;

c. The administration of any intravenous drug;

d. The administration or prescription of drugs that are not recommended for unmonitored home use;

e. The administration of nitrous oxide with more than one enteral drug; and

f. The moderate sedation of an ASA category 3-4 patient or a pediatric patient as defined pursuant to subrule 29.4(4)c .

29.5(3) The decision as to whether a patient is a suitable candidate for moderate sedation must be made by a permit holder.

29.5(5) No dentist shall use or permit the use of moderate sedation for dental patients in a facility that has not successfully passed an equipment inspection pursuant to the requirements of rule 29 .9 . A dentist holding a permit shall be subject to review and facility inspection at a frequency described in rule 29.9(3).

650—29.6(153) Moderate sedation permit holders. 29.6(1) If a dentalDRAFT facility has not been previously inspected, no permit shall be issued until the facility has been inspected and successfully passed.

29.6(2) Permits shall be renewed biennially at the time of license renewal following submission of proper application and may involve board re-evaluation of credentials, facilities, equipment, personnel, and

Dental Board [650] Ch. 29, p. 10

procedures of a previously qualified dentist to determine if the dentist is still qualified. The appropriate fee for renewal as specified in 650—Chapter 15 of these rules must accompany the application.

29.6(3) Upon the recommendation of the anesthesia credentials committee that is based on the evaluation of credentials, facilities, equipment, personnel and procedures of a dentist, theboard may determine that restrictions may be placed on a permit.

29.6(4) Permit holders shall follow the American Dental Association’s guidelines , or other guidelines prior approved by the board, for the use of sedation and general anesthesia for dentists, except as otherwise specified in these rules.

29.6(5) The dentist shall ensure that each facility where sedation services are provided is permanently equipped pursuant to subrule 29.9 and staffed with trained auxiliary personnel capable of reasonably handling procedures, problems and emergencies incident to the administration of moderate sedation. Auxiliary personnel shall maintain current certification in Advanced Cardiac Life Support (ACLS) or Pediatric

Advanced Life Support (PALS) basic life support successfully complete the Dental Anesthesia Assistant

National Certification Examination (DAANCE) as offered by the American Association of Oral and

Maxillofacial Surgeons (AAOMS) or substantially-equivalent program or examination prior-approved by the board and be capable of administering basic life support. Current certification means certification by an organization on an annual basis or, if that certifying organization requires certification on a less frequent basis, evidence that the permit holder has been properly certified for each year covered by the renewal period. In addition, the course must include a clinical component.

29.6(6) A dentist administering moderate sedation must document and maintain current certification in

Advanced Cardiac Life Support (ACLS). A dentist administering moderate sedation to pediatric patients may maintain current certificationDRAFT in Pediatric Advanced Life Support (PALS) in lieu of ACLS. Current certification means certification by an organization on an annual basis or, if that certifying organization requires certification on a less frequent basis, evidence that the permit holder has been properly certified for each year covered by the renewal period. In addition, the course must include a clinical component.

Dental Board [650] Ch. 29, p. 11

29.6(7) A dentist who is performing a procedure for which moderate sedation is being employed administering moderate sedation in a dental facility shall utilize the not administer the pharmacologic agents and monitor the patient without the presence and assistance of at least one licensed dentist, dental hygienist, nurse, or registered dental assistant qualified auxiliary personnel in the room who is qualified under subrule

29.6(5). The qualified personnel shall be present in the treatment room and continually monitor the patient for the duration of the sedation service.

29.6(8) Dentists qualified to administer moderate sedation may administer nitrous oxide inhalation analgesia provided they meet the requirement of rule 650— 29.2 (153).

29.6(9) If moderate sedation results in a general anesthetic state, the rules for deep sedation/general anesthesia apply.

29.6(10) A dentist utilizing moderate sedation on pediatric or ASA category 3 or 4 patients must have completed an accredited residency program that includes formal training in anesthesia and clinical experience in managing pediatric or ASA category 3 or 4 patients. A dentist who does not meet the requirements of this subrule is prohibited from utilizing moderate sedation on pediatric or ASA category 3 or 4 patients.

29.6(11) Use of capnography or pretracheal/precordial stethoscope required for moderate sedation providers permit holders.Beginning January 1, 2018, all moderate sedation permit holders shall use require the use of capnography to monitor end-tidal CO 2 unless precluded or invalidated by the nature of the patient, procedure or equipment. In cases where the use of capnography is precluded or invalidated for the reasons listed previously, a pretracheal or precordial stethoscope must be used to continually monitor the auscultation of breath sounds at all facilities where permit holders provide sedation.

650—29.7(153) DefinitionDRAFT of deep sedation/general anesthesia. 29.7(1) A controlled state of unconsciousness, produced by a sedative, which render a patient unconscious, accompanied by a partial or complete loss of protective reflexes, including inability to independently maintain an airway and respond purposefully to physical stimulation or verbal command shall

Dental Board [650] Ch. 29, p. 12

constitute deep sedation/general anesthesia,

29.7(2) The administration of sedative agents intended for deep sedation/general anesthesia (e.g.

Propofol, Ketamine, Dilaudid) shall constitute deep sedation/general anesthesia.

29.7(2) If a licensee intends to administer deep sedation/general anesthesia in a dental facility, the dentist must hold an active general anesthesia sedation permit issued by this board, and comply with all requirements for administering deep sedation/general anesthesia in a dental facility as established in this chapter.

29.7(2) No dentist shall use or permit delegate the use administration of deep sedation/general anesthesia or moderate sedation in a dental office for dental patients, unless the dentist possesses a current permit issued by the board. No dentist shall use or permit the use of deep sedation/general anesthesia or moderate sedation for dental patients in a facility that has not successfully passed an equipment inspection pursuant to the requirements of rule 29.9 . A dentist holding a permit shall be subject to review and facility inspection at a frequency described in rule 29.9(3) .

650—29.8(153) Deep sedation/general anesthesia permit holders.

29.8(1) If a dental facility has not been previously inspected, no permit shall be issued until the facility has been inspected and successfully passed.

29.8(2) Permits shall be renewed biennially at the time of license renewal following submission of proper application and may involve board re-evaluation of credentials, facilities, equipment, personnel, and procedures of a previously qualified dentist to determine if the dentist is still qualified. The appropriate fee for renewal as specified inDRAFT 650—Chapter 15 of these rules must accompany the application. 29.8(3) Upon the recommendation of the anesthesia credentials committee that is based on the evaluation of credentials, facilities, equipment, personnel and procedures of a dentist, theboard may determine that restrictions may be placed on a permit.

Dental Board [650] Ch. 29, p. 13

29.8(4) Permit holders shall follow the American Dental Association’s guidelines , or other guidelines prior-approved by the board, for the use of sedation and general anesthesia for dentists, except as otherwise specified in these rules.

29.8(5) The dentist shall ensure that each facility where sedation services are provided is permanently equipped pursuant to rule 29.9 and staffed with trained auxiliary personnel capable of reasonably handling procedures, problems and emergencies incident to the administration of general anesthesia. Auxiliary personnel shall maintain current certification in Advanced Cardiac Life Support (ACLS) or Pediatric

Advanced Life Support (PALS) basic life support successfully complete the Dental Anesthesia Assistant

National Certification Examination (DAANCE) as offered by the American Association of Oral and

29.8(6) A dentist administering deep sedation/general anesthesia must document and maintain current certification in Advanced Cardiac Life Support (ACLS). Current certification means certification by an organization on an annual basis or, if that certifying organization requires certification on a less frequent basis, evidence that the permit holder has been properly certified for each year covered by the renewal period. In addition, the course must include a clinical component.

29.8(7) A dentist who is performing a procedure for which administering deep sedation/general anesthesia was induced in a dental facility shall not administer the general anesthetic and monitor the patient without the presence DRAFT and utilize the assistance of at least two personnel, such as a licensed dentist, dental hygienist, nurse, or registered dental assistant, who are qualified under subrule 29.3(3). The qualified personnel shall be present in the treatment room and continually monitor the patient for the duration of the sedation service.

Dental Board [650] Ch. 29, p. 14

29.8(8) A dentist qualified to administer deep sedation/general anesthesia under this rule may administer moderate sedation and nitrous oxide inhalation analgesia provided the dentist meets the requirements of rule 650— 29. 2 (153).

29.8(9) Use of capnography and pretracheal or precordial stethoscope.

a. Consistent with the practices of the American Association of Oral and Maxillofacial Surgeons

(AAOMS), all general anesthesia/deep sedation permit holders shall use capnography at all facilities where they provide sedation beginning January 1, 2014.

b. All general anesthesia/deep sedation permit holders shall use a pretracheal or precordial stethoscope to continually monitor auscultation of breath sounds beginning January 1, 2018.

29.8(10) Sedation permit providers who utilize deep sedation/general anesthesia in a dental facility shall maintain an open airway for the duration of the sedation.

650—29.9(153) Facility Inspections.

29.9(1) The dentist shall maintain and be trained on the following equipment at each dental facility where sedation is provided: capnography to monitor end-tidal CO 2, pretracheal or precordial stethoscope, EKG monitor, positive pressure oxygen, suction, laryngoscope and blades, endotracheal tubes, magill forceps, oral airways, stethoscope, blood pressure monitoring device, pulse oximeter, emergency drugs, defibrillator. A licensee may submit a request to the board for an exemption from any of the provisions of this subrule.

29.9(2) The actual costs associated with the on-site evaluation of the facility shall be the primary responsibility of the licensee. The cost to the licensee shall not exceed the fee as specified in 650—Chapter 15.

29.9(3) Frequency of facility inspections.

a. The board or designated agents of the board or anesthesia credentials committee will conduct ongoing facility inspections ofDRAFT each primary facility every five years, with the exception of the University of Iowa College of Dentistry, hospitals and outpatient surgical clinics . Satellite facilities may be inspected at the discretion of the board. A permit holder must provide a written attestation confirming that all satellite facilities meet the provisions of this section.

Dental Board [650] Ch. 29, p. 15

b. The University of Iowa College of Dentistry shall submit written verification to the board office every five years indicating that it is properly equipped pursuant to this chapter.

29.9(4) Change or addition of a sedation facility.

a. A sedation permit holder shall notify the board office in writing within 60 days of a change in location of an approved sedation facility.

b. A sedation permit holder shall notify the board office in writing within 60 days of an additional facility locations.

650—29.10(153) Delegation of moderate sedation and general anesthesia services.

29.10(1) A licensed dentist who holds a current sedation permit may delegate the administration of sedation in a dental facility to another dentist who holds a current sedation permit issued by this board, an anesthesiologist currently licensed by the Iowa Board of Medicine, or a certified registered nurse anesthetist currently licensed by the Iowa Board of Nursing provided the licensees meet the following requirements:

a. A licensed dentist who holds a current moderate sedation permit may delegate the administration of moderate sedation;

b. A licensed dentist who holds a current general anesthesia permit may delegate the administration of moderate sedation or deep sedation/general anesthesia; and

c. The licensed dentist who delegates the administration of sedation services must remain present in the treatment room while the patient is under moderate sedation or deep sedation/general anesthesia.

29.10(2) A dentist who delegates the administration of moderate sedation and deep sedation/general anesthesia services must maintain a permanently-equipped facility pursuant to subrule 29.9 . 29.10(3) A licensedDRAFT dentist who delegates the administration of moderate sedation or deep sedation/general anesthesia services shall follow the American Dental Association’s guidelines, or other guidelines prior approved by the Board, for the use of sedation and general anesthesia for dentists, except as otherwise specified in these rules.

Dental Board [650] Ch. 29, p. 16

29.10(4) A dentist who is performing a procedure for which moderate sedation is being administered shall not delegate the administration of the pharmacologic agents in a dental facility and monitor the patient without the presence and assistance of at least one qualified auxiliary personnel in the room who is qualified under subrule 29.6(5) .

29.10(5) A dentist who is performing a procedure for which deep sedation/general anesthesia is being administered in a dental facility shall not delegate the administration of the pharmacologic agents and monitor the patient without the presence and assistance of at least two qualified auxiliary personnel in the room who are qualified under subrule 29.8(5) .

29.10(6) A licensed dentist, who does not hold a current qualification to sedate pediatric and/or ASA category 3-4 patients as part of their moderate sedation permit, shall not delegate the administration of moderate sedation to pediatric or ASA category 3 or 4 patients.

29.10(7) Entries in the patient record shall comply with the requirements established in subrule 29.11 (2).

29.10(8) Permit holders may administer sedation on behalf of another licensed dentist, who does not hold a sedation permit, provided the permit holder complies with the following:

a. The sedation permit holder completes a pre-operative evaluation of the patient, and determines the patient is a suitable candidate for sedation;

b. The sedation permit holder administers the administration of the moderate or deep sedation/general anesthesia;

c. The sedation is provided at a dental facility, which has successfully passed an inspection pursuant to the requirements of 29.9 , at the University of Iowa College of Dentistry, hospital or outpatient surgery clinic; and d. The sedationDRAFT permit holder complies with all other rules herein.

650— 29.11 (153) Record keeping.

29.11(1) Minimal sedation. An appropriate sedative record must be maintained and must contain the names

Dental Board [650] Ch. 29, p. 17

of all drugs administered, including local anesthetics and nitrous oxide, dosages, time administered, and monitored physiological parameters, including oxygenation, ventilation, and circulation.

29.11(2) Moderate or deep sedation. The patient chart must include preoperative and postoperative vital signs, drugs administered, dosage administered, anesthesia time in minutes, and monitors used. Pulse oximetry, heart rate, respiratory rate, and blood pressure must be recorded continually until the patient is fully ambulatory. The chart should contain the name of the person to whom the patient was discharged.

29.11(3) Nitrous oxide inhalation analgesia. The patient chart must include the concentration administered and duration of administration, as well as any vital signs taken.

[ARC 8369B, IAB 12/16/09, effective 1/20/10; ARC 8614B, IAB 3/10/10, effective 4/14/10; ARC 1194C, IAB 11/27/13, effective 11/4/13] These rules are intended to implement Iowa Code sections 153.33 and 153.34 .

650— 29.12 (153) Reporting of adverse occurrences related to sedation, nitrous oxide inhalation analgesia, and antianxiety premedication.

29.12 (1) Reporting. All licensed dentists in the practice of dentistry in this state must submit a report within a period of seven days to the board office of any mortality or other incident which results in temporary or permanent physical or mental injury requiring hospitalization of the patient during, or as a result of, antianxiety premedication, nitrous oxide inhalation analgesia, or sedation. The report shall include responses to at least the following:

a. Description of dental procedure.

b. Description of preoperative physical condition of patient.

c. List of drugs and dosage administered.

d. Description, in detail, of techniques utilized in administering the drugs utilized. e. Description ofDRAFT adverse occurrence: 1. Description, in detail, of symptoms of any complications, to include but not be limited to onset, and type of symptoms in patient.

Dental Board [650] Ch. 29, p. 18

2. Treatment instituted on the patient.

3. Response of the patient to the treatment.

f. Description of the patient’s condition on termination of any procedures undertaken.

29.12 (2) Failure to report. Failure to comply with subrule 29.12 (1), when the occurrence is related to the use of sedation, nitrous oxide inhalation analgesia, or antianxiety premedication, may result in the dentist’s loss of authorization to administer sedation, nitrous oxide inhalation analgesia, or antianxiety premedication or in any other sanction provided by law.

[ARC 8614B, IAB 3/10/10, effective 4/14/10; ARC 1194C, IAB 11/27/13, effective 11/4/13]

650—29.13(153) Requirements for issuance of a moderate sedation or general anesthesia permit.

29.13 (1) No dentist shall use or permit the use of deep sedation/general anesthesia or moderate sedation for dental patients, unless the dentist possesses a current permit issued by the board. No dentist shall use or permit the use of deep sedation/general anesthesia or moderate sedation for dental patients in a facility that has not successfully passed an equipment inspection pursuant to the requirements of rule 29. 9 . A dentist holding a permit shall be subject to review and facility inspection at a frequency described in subrule 29.9(3).

29.13 (2) An application for moderate sedation or general anesthesia permit is submitted to the board, and includes the fee as specified in 650 - Chapter 15.

29.13 (3) The applicant for moderate sedation permit has completed education and training that complies with the following;

a. Successfully completed a training program approved by the board that meets the American

Dental Association Guidelines for Teaching Pain Control and Sedation to Dentists and Dental

Students or another board-approved program, and that consists of a minimum of 60 hours of instructionDRAFT and management of at least 20 patients; and b. Successfully completed training that includes rescuing patients from a deeper level of

sedation than intended, including managing the airway, intravascular or intraosseous access,

Dental Board [650] Ch. 29, p. 19

and reversal medications; or

c. Has submitted evidence of successful completion of an accredited residency program that

includes formal training and clinical experience in moderate sedation, which is approved by

the board.

29.13 (4) The applicant for general anesthesia permit has completed education and training that complies with the following;

a. Successful completion an advanced education program accredited by the Commission on

Dental Accreditation that provides training in deep sedation and general anesthesia;

b. Successful completion of a minimum of one year of advanced training in anesthesiology and

related academic subjects beyond the undergraduate dental school level in a training program

approved by the anesthesia credentials committee; and

c. Completion of formal training in airway management.

29.13 (5) All facilities where the applicant intends to provide sedation services have been inspected by the board or designated agent within five years of the date of application pursuant to rule 29.9 ;

29.13 (6) Applicant must document and maintain current certification in Advanced Cardiac Life

Support (ACLS). Current certification means certification by an organization on an annual basis or, if that certifying organization requires certification on a less frequent basis, evidence that the permit holder has been properly certified for each year covered by the renewal period. In addition, the course must include a clinical component.

29.13 (7) The applicant has completed a peer review evaluation, as may be required by the anesthesia credentials committee board, prior to issuance of a permit. 29.13 (8) A licensedDRAFT dentist who has been utilizing deep sedation/general anesthesia in a competent manner for the five-year period preceding July 9, 1986, but has not had the benefit of formal training as outlined in this rule, may apply for a permit provided the dentist fulfills the provisions set forth in 29.13(2),

29.13(5), 29.13(6), and 29.13(7).

Dental Board [650] Ch. 29, p. 20

[ARC 8614B, IAB 3/10/10, effective 4/14/10; ARC 1194C, IAB 11/27/13, effective 11/4/13; ARC 3491C, IAB 12/6/17, effective 1/10/18]

650— 29.14 (153) Review of permit applications.

29.14 (1) Review by board staff. Upon receipt of a completed application, board staff will review the application for eligibility. Following staff review, a public meeting of the anesthesia credentials committee

(ACC) ACC will be scheduled.

29.14 (2) Review by the anesthesia credentials committee (ACC). Following review and consideration of an application, the ACC may at its discretion:

a. Request additional information;

b. Request an investigation;

c. Request that the applicant appear for an interview;

d. Recommend issuance of the permit;

e. Recommend issuance of the permit under certain terms and conditions or with certain restrictions;

f. Recommend denial of the permit;

g. Refer the permit application to the board for review and consideration without recommendation; or

h. Request a peer review evaluation.

29.13 (3) Review by executive director. If, following review and consideration of an application, the ACC recommends issuance of the permit with no restrictions or conditions, the executive director as authorized by the board has discretion to authorize the issuance of the permit.

29.13 (4) Review by board. The board shall consider applications and recommendations from the ACC. The board may take any of the following actions:

a. Request additional information; b. Request an investigation;DRAFT c. Request that the applicant appear for an interview;

d. Grant the permit;

Dental Board [650] Ch. 29, p. 21

e. Grant the permit under certain terms and conditions or with certain restrictions; or

f. Deny the permit.

29.14 (5) Right to defer final action. The ACC or board may defer final action on an application if there is an investigation or disciplinary action pending against an applicant who may otherwise meet the requirements for permit until such time as the ACC or board is satisfied that issuance of a permit to the applicant poses no risk to the health and safety of Iowans.

29.14 (6) Appeal process for denials. If a permit application is denied, an applicant may file an appeal of the final decision using the process described in rule 650—11.10 (147).

[ARC 1194C, IAB 11/27/13, effective 11/4/13]

650— 29.15 (153) Renewal. A permit to administer deep sedation/general anesthesia or moderate sedation shall be renewed biennially at the time of license renewal. Permits expire August 31 of every even-numbered year.

29.15 (1) To renew a permit, a licensee must submit the following:

a. Evidence of renewal of ACLS certification. PALS certification is also acceptable if the permit holder provides sedation services pediatric patients.

b. A minimum of six hours of continuing education in the area of sedation. These hours may also be submitted as part of license renewal requirements.

c. The appropriate fee for renewal as specified in 650—Chapter 15.

29.15 (2) Failure to renew the permit prior to November 1 following its expiration shall cause the permit to lapse and become invalid for practice.

29.15 (3) A permit that has been lapsed may be reinstated upon submission of a new application for a permit in complianceDRAFT with rule 650— 29 .13 (153) and payment of the application fee as specified in 650—Chapter 15.

[ARC 8614B, IAB 3/10/10, effective 4/14/10; ARC 1194C, IAB 11/27/13, effective 11/4/13]

Dental Board [650] Ch. 29, p. 22

650— 29.16 (147,153,272C) Grounds for nonrenewal. A request to renew a permit may be denied on any of the following grounds:

29.16 (1) After proper notice and hearing, for a violation of these rules or Iowa Code chapter 147 , 153 ,or

272C during the term of the last permit renewal.

29.16 (2) Failure to pay required fees.

29.16 (3) Failure to obtain required continuing education.

29.16 (4) Failure to provide documentation of current ACLS or PALS certification.

29.16 (5) Failure to provide documentation of maintaining a properly equipped facility.

29.16 (6) Receipt of a certificate of noncompliance from the college student aid commission or the child support recovery unit of the department of human services in accordance with 650—Chapter 33 or

650—Chapter 34.

[ARC 1194C, IAB 11/27/13, effective 11/4/13]

650— 29.17 (153) Anesthesia credentials committee.

29.17 (1) The anesthesia credentials committee is a peer review committee appointed by the board to assist the board in the administration of this chapter. This committee shall be chaired by a member of the board and shall include at least six additional members who are licensed to practice dentistry in Iowa. At least four members of the committee shall hold deep sedation/general anesthesia or moderate sedation permits issued under this chapter.

29.17 (2) The anesthesia credentials committee shall perform the following duties at the request of the board: a. Review all permitDRAFT applications and make recommendations to the board regarding those applications. b. Conduct site visits at facilities under rule 650— 29.9 (153) and report the results of those site visits to the board. The anesthesia credentials committee may submit recommendations to the board regarding the

Dental Board [650] Ch. 29, p. 23

appropriate nature and frequency of site visits.

c. Perform professional evaluations and report the results of those evaluations to the board.

d. Other duties as delegated by the board or board chairperson.

[ARC 1194C, IAB 11/27/13, effective 11/4/13]

650— 29.18 (153) Noncompliance. Violations of the provisions of this chapter may result in revocation or suspension of the dentist’s permit or other disciplinary measures as deemed appropriate by the board.

DRAFT STATE OF IOWA IOWA DENTAL BOARD

KIM REYNOLDS, GOVERNOR JILL STUECKER ADAM GREGG, LT. GOVERNOR EXECUTIVE DIRECTOR

September 18, 2018

Dear Dr.

I am corresponding today on behalf of the Anesthesia Credentials Committee for the Iowa Dental Board (IDB). Our committee provides supporting commentary and recommendations to the IDB when the board makes decisions about sedation and anesthesia services provided by dentists in Iowa. Iowa dental providers who provide moderate sedation, deep sedation or general anesthesia services in their office must first obtain a state-issued permit under the direction of the IDB. Our committee assists in reviewing the credentials of the applicants for this process. Our guidelines typically follow the ADA guidelines for the use of sedation and general anesthesia by dentists. Permit holders are then required to document training beyond that of the baseline skills acquired in the dental school experience before receiving their permit. Iowa dentists who desire to provide deep sedation or general anesthesia services are required to demonstrate a more advanced level of training when compared to permits issued for moderate sedation.

Recently the IDB has received several requests for waivers to this process. The waivers request authorization for dental providers to delegate the provision of anesthesia related services to a second anesthesia specific provider. The waivers are for services to be provided in an office-based setting with the adjunct of a deep sedation or general anesthesia. The IDB subsequently requested input from the anesthesia committee because of the deep sedation or general anesthesia component.

Early discussions by the Anesthesia Credentials Committee recognized the benefits of a dedicated anesthesia provider. However, the committee has suggested that even if dentists are going to delegate the anesthesia specific services, the dental service provider still needs to be obligated to some minimum level of anesthesia specific training. The reasoning behind this position is that there must be a balance of understanding and a shared core of knowledge between the dental service provider and the anesthesia service provider. Providing dental procedure services with the adjunct of deep sedation or general anesthesia in a dental office setting is a completely different circumstance than managing a patient whose protective reflexes are intact. This point must be underscored when an open airway deep sedation or general anesthesia is anticipated in the office setting.

The Anesthesia Credentials Committee subsequently recommended that Iowa dental service providers who delegate anesthesia specific services in their dental offices should be required to demonstrate a minimum level of anesthesia specific training. This minimum level was determined to be the training for, and the receipt of, a moderate sedation permit in Iowa. The committee’s position has met resistance.

The focus question in this debate is: Do general dentists with no sedation or anesthesia training beyond the training that they receive in dental school have the background knowledge and experience necessary to treat patients who are receiving deep sedation or general anesthesia in an office setting? For this question we will assume that we have a well-skilled anesthesia specific provider. However, we will not necessarily assume that the anesthesia provider has knowledge of dental procedures. We will also assume that the most likely anesthesia service will be an open airway or non-intubated deep sedation or general anesthesia. This focus question is directed toward office-based procedures only, not those procedures

400 SW 8th STREET, SUITE D, DES MOINES, IA 50309- 4687 PHONE:515- 281- 5157 FAX:515- 281- 7969 http://www.dentalboard.iowa.gov provided in an outpatient hospital or outpatient surgical center. The committee recognizes that those institutions are more rigorously controlled and typically have several layers of safeguards built in. Additionally, procedures are more typically completed with an intubated and protected airway in those facilities.

The IDB Anesthesia Credentials Committee is therefore reaching out to experts in the field of dental anesthesia and, in particular, those who are familiar with the provision of dental services with the adjunct of deep sedation or general anesthesia. We respectfully request your comments related to our focus question and a short series of questions along a related line of considerations. Please take the time to provide your comments.

Related questions:

1. Should the dental service provider who is delegating the deep sedation or general anesthesia service in the office setting be required to have some minimum level of actual deep sedation or general anesthesia training to better understand the interaction of anesthesia and dental services?

2. Should dental hygienists who provide hygiene services for patients receiving deep sedation or general anesthesia in an office setting be required to have some minimum level of sedation or anesthesia training to better understand the interaction of anesthesia and hygiene services?

3. Does a dental provider who is delegating both hygiene and anesthesia services need to be physically present in the treatment room while hygiene services are provided with the adjunct of deep sedation or general anesthesia in an office setting?

4. If you are involved with a residency training program, what experiences do your residents have with treating patients with deep sedation or general anesthesia (not moderate sedation)? In these circumstances are patients managed in a clinic environment or in the O.R.?

5. In your area, how are patients who require deep sedation or general anesthesia as an adjunct to general dental procedures typically managed?

6. In your area, are adjunctive deep sedation or general anesthesia services typically completed with an “open airway” technique or an “airway device” technique when completed in the office setting?

A final statement would be this: We are all too familiar with several unfortunate experiences that our colleagues in dentistry have encountered in recent years. Our committee’s concern is that if we as dentists do not act to monitor our own profession, we are failing in our obligations to the public and to other members of our profession. We may lose control of our own profession and then be subject to monitoring and regulation from outside the profession. When making our recommendations, we desire to be informed and we desire to be fair. We therefore reach out to you and our colleagues in dentistry for your expertise.

Thank you,

John Frank, DDS On the behalf of the Anesthesia Credentials Committee for the Iowa Dental Board Hospital Dentistry Institute

Oral and Maxillofacial Surgery 200 Hawkins Drive, 51300 PFP Iowa City IA 52242 319-356-1981 Tel 319-353-6923 Fax August 24, 2018 www.uihealthcare.org

John Frank, DDS and Anesthesia Credentials Committee Iowa Dental Board 400 SW 8th Street Suite D Des Moines IA 50309-4687

Dear Dr. Frank and the Anesthesia Credentials Committee,

General dentists with no sedation or anesthesia training beyond the training they received in dental school do NOT have the background knowledge or experience necessary to safely treat patients receiving “non-intubated” deep sedation or general anesthesia in an office setting, even with a well-skilled anesthesia provider. Airway protection is the over- riding concern: protection from secretions; irrigation; broken pieces of teeth; blood; crowns or other loose dental components; etc. The importance of airway protection cannot be overstated nor learned without formal training and experience. The skilled anesthesia provider cannot be expected to prevent inadvertent airway compromise from the general dental provider who is working in the mouth. The overseeing general dentist must be skilled in airway management and thereby understand the importance of protecting it.

Our experienced medical anesthesiologists at the University of Iowa are hesitant to provide non-intubated deep sedation or general anesthesia for general dental procedures. They were surprised to learn how many “potential airway stimulants” occur with general dental procedures. In fact, general dental patients that require more than controlled procedural sedation to provide dental care at the University of Iowa are intubated for airway protection.

Clearly we do NOT endorse this anesthesia model in the general dental office out of concern for patient safety. We do not believe the airway can be controlled adequately or protected for many if not most general dental procedures. Even one anesthesia related death in a dental office is too many. Bottom line, if a controlled, light procedural sedation is not adequate to perform dental cleanings or general dental procedures in an office setting, consideration for an operating room setting with intubation is recommended. Page 2 Anesthesia Credentials Committee Iowa Dental Board August 24, 2018

However, should this anesthesia model be pushed forward, the following recommendations are offered:

1. The general dentist must receive advanced anesthesia training beyond what is taught in dental school and must include live airway training. At a minimum, the general dentist MUST meet the state requirements for a moderate sedation permit.

2. The general dentist must be present in the room to perform or staff the entire dental procedure(s) for patients undergoing deep sedation or general anesthesia in conjunction with a skilled anesthesia provider.

3. The general dentist and any other dental provider must be current with BLS and ACLS or PALS.

4. The patient undergoing dental procedures with deep sedation or general anesthesia must have a formal history and physical (or equivalent document with key elements) completed within 30 days of the procedure(s) and it must be updated the day of the procedure(s) to rule out health changes, upper respiratory infection, recent drug use, pregnancy, etc. Documentation must include ASA status, BMI and METS criteria or equivalent.

5. Standardized anesthesia charting is mandatory and must be contemporaneous.

6. Only ASA 1 and 2 category patients should be considered viable for this anesthesia model. Special restrictions are needed for pediatric patients (definition?), elderly patients and those patients with elevated body mass index.

7. Recurring office anesthesia evaluations by peers or designated agencies must be done; these office evaluations must include and document consistent, comprehensive office emergency simulations.

8. Offices must be fully equipped to provide adequate monitoring including pulse oximetry, capnography, ECG tracing, precordial stethoscope, blood pressure and pulse. Additionally, offices must be fully equipped to treat all potential anesthetic emergencies (equipment and drugs).

Please do not hesitate to contact us should you have any questions.

Page 3 Anesthesia Credentials Committee Iowa Dental Board August 24, 2018

Most sincerely,

______Kirk Fridrich, D.D.S., M.S. F.A.C.S.

______Richard Burton, D.D.S., M.S., F.A.C.S.

______Steven Fletcher, D.D.S. F.A.C.S.

______Aaron Figueroa, DDS

______Douglas Kendrick, D.D.S.

______Kyle Stein, D.D.S., F.A.C.S.

William Synan, D.D.S.

Indiana Office Based Anesthesia 3750 Guion Road, Suite 225 Indianapolis, IN 46222-7606

p: 317,924.2390 f: 317.924.2391 www.indyoba.com

SLP 11 Z018 September ~i, 2018

John Frank, DDS IOWA DENTAL BOARD Anesthesia Credentials Committee Iowa Dental Board 400 SW 8th Street, Suite D Des Moines, IA 50309-4687

Dear Dr. Frank/

Thank you for the opportunity to comment on the questions currently being reviewed by the iowa Dental Board Anesthesia Credentials Committee. I agree these questions are very important and applaud your effort to gain a wide consensus from experienced providers.

Here are my thoughts on the questions you listed:

1. Should the dental service provider who is delegating the deep sedation or genera! anesthesia service in the office setting be required to have some minimal level of actual deep sedation or general anesthesia training to better understand the interaction of anesthesia and dental services?

Absoluteiy. In my career i have worked with a wide variety of dentists that ranges from dentists with no formal training beyond dental school to dual degree specialists. In more specific terms/ that represents approximately 10,000 cases in a period of about 26 years. In my experience/ the patient is better served when the dental provider has undergone some degree of advanced training or specific sedation training. Our scientific literature confirms that the degree of normal muscle tone that keeps an airway open during consciousness is markedly reduced/ or absent during deep sedation and general anesthesia. Based on my own observations, it is extremely easy for dental operators to obstruct or compromise an airway in the anesthetized patient, even when a separate anesthesia provider is managing the airway. Advanced training provides a familiarity with and respect for the airway that is not achievable without mentored clinicaf instruction. This is particularly important when the anesthesia provider is using a nonintubated airway management technique, but also applies to cases with endotracheai intubation. At a minimum, I think the dentist should have moderate sedation training, since that ievel of training includes exposure to patients with deep sedation and general anesthesia.

2. Should denta! hygienists who provide services for patients receiving deep sedation or general anesthesia in an office setting be required to have some minimum level ofsedation or anesthesia training to better understand the interaction of anesthesia and hygiene services?

Yes/ for the same reason stated in the question above. This is most apparent to me when I am providing general anesthesia for a dentist who employs an expanded functional dental assistant or hygienist. Very few auxiliaries and hygienists have the benefit of training to prepare them for practicing in the context ofdeepsedation and general anesthesia. There are certainly exceptions/ but i am not aware of any specific training requirements in their respective curricula that prepare them forthis experience. Inexperienced operators are often less aware of the hazards posed by excessive traction on the mandible, excessive use of irrigation/ inadequate debridement and inadvertent obstruction, Providing a basic orientation course for hygienists would increase the margin of safety for patients receiving office- based deep sedation and general anesthesia for dental hygiene services.

If the delegating dental provider is using a physician or dentist anesthesiologjst, I do not believe there is a need to be in the room, since hygienists do not require the presence of a delegating dentist in the treatment room for routine services. However, 1 base this on my own practice of always performing office-based anesthesia with the assistance of my own nurse, independent of the office I am serving. Some physician and dentist anesthesiologists may want the delegating dentist to be available to assist in certain anesthetic urgencies or emergencies. in that case, the delegating dentist should be on the premises and immediately available.

4. if you are involved with a residency program, what experiences do your residents have with treating patients with deep sedatson and general anesthesia? fn these circumstances are patients managed in a clinic environment or in the OR?

Residents from the Riley Hospital Pediatric Dental Residency program shadow me in my dental anesthesia practice. I provide approximately 15-20 office-based general anesthetics per week to approximately 26 dentists in the Indianapolis area. Greater than 80% are pediatric dental practices. All anesthetics are office-based and essentially all are general anesthetics. Each resident spends a minimum of two full days as part of their scheduled offsite experiences. During that time, they gain observationai experience, as well as experience in airway management and delivering intramuscular injections. The purpose of this experience is to provide practical experience that may guide them in their future practices when addressing emergencies during any form of sedation or anesthesia.

5. In your area, how are patients who require deep sedation or general anesthesia as an adjunct to general dental procedures typically managed?

Given that the patients requiring this service are most often young children or special needs patients, practices typically employ a dentist anesthesiologist to provide office-based deep sedation/general anesthesia or take their patients to a hospital or surgery center. To my knowledge/ there are approximately 8 "10 facilities that accommodate this service. Several of the pediatric dentists I work with report long wait times to treat patients in a hospital or surgery center (typically several months).

6. In your area, are adjunctive deep sedation or general anesthesia services typically completed with an open airway "technique or an "airway device" technique when completed in the office setting.

The selection of an airway management technique is dependent upon the type of patient being treated and the preference of the anesthesia provider. I don't believe there is a strong correlation between the geographic area and airway management techniques, in my own practice, we currently intubate approximately 30% to 40% of patients. Intubation is preferred for longer, more complex cases/ particularly when bleeding or the use of irrigation or impressions may pose a potential threat to an open airway. I also prefer intubation when preoperative examination of the patient reveals large tonsils or other anatomic factors that increase the risk for obstruction under general anesthesia. In addition to intubation/1 often use a laryngeal mask airway (LMA) for airway management. The "open airway" cases I perform are not truly open, as I routinely place nasopharyngeal airways with the tip approximately 5mm from the arytenoid cartilage of the larynx and pack the oropharynx with a compressible throat sponge/ using direct laryngoscopy. All patients receive supplemental oxygen and capnography with this technique and the head is immobilized prior to treatment. In my experience, this type of nonintu bated airway management technique works well when working with experienced dental operators on short cases (less than 45 minutes).

Thank you again for the opportunity to provide comments on these important questions. In dosing/ I would also like to strongly recommend that all providers of office-based anesthesia !og their clinical outcomes and participate in a shared database for other dental office-based anesthesia providers. This enables the development of best practices and reliable outcomes data and enhances safety. There are several models for this that allow practitioners to participate in away that protects the individual identity of patients and practitioners while providing important safety data.

Sincerely,

MarkA.Saxen/DDS, PhD September 27, 2018

RE: Sedation

Members of the Iowa Dental Board,

I want to commend and thank you for your services on the board. Your efforts are appreciated!

In regard to your recent discussions on sedation in a dental ‘facility’, it is obtusely obvious that a lot of dogs have come to this fight; each senses they have something to gain or lose as a result of these hearings and your eventual vote. You have been presented with truths, bias, and hyperbole. Now you have the tough job of separating these distillates before arriving at your final decision.

Sedation has been a lifelong interest of mine, stimulated in oral surgery blocks and rotations in dental school at the University of Iowa in 1977/1978. I was encouraged and mentored by many of our fine professors and faculty to continue my learning. We had no monitors, no pulse oximeters, no short acting drugs, no reversal agents, no precordial stethoscopes, no IV catheters, less knowledge, less technology, and less safe guards. By today’s standard, we lacked much. What we did not lack was the expectation from our mentors that we could and would be of service to the people in our communities. We commenced with confidence and fortitude.

In my 40 years of general practice, I am nearing my 3,000th successful sedation as a solo provider. I say this with all humility and only to salute and honor the myriad of mentors that have made this possible. I am a product of their generous sharing of knowledge, time, and belief in me.

We are now raising the next generation of our profession. Who do we envision them to be? We need to cultivate their desire and enthusiasm and be mentors to them, but it is imperative that we have dental practice laws that facilitate this process. I was confused and flabbergasted re‐reading pages 1‐19 of Chapter 29 of the Iowa Code and Rules. With its tangled web of rules and regulations, it loudly shouted, “Doubt! Fear! Mistrust!” And now you appear poised to add yet additional strands to that web by “searching for the best model”, as recently referenced by a board member?

Why do we look to hang our hat on only one model? Are the resources available in the Des Moines metro the same as they are in much of rural Iowa? Absolutely not! Are the people residing in more rural areas less needful of sedation services? Emphatically no! We have taken our eye off the ball – serving the people of Iowa and their access to care – while continuing to weave this nearly impenetrable blockade for practitioners, particularly our young ones.

I think you would do well to pause, table this item for 6 months, and really listen to what the dentists and their patients in the state of Iowa are saying. Sedation can be safe, effective, available, and affordable if we are all committed to a spirit of excellence within the dental sedation community.

Sincerely,

Dean R Hussong, DDS., S.C. 10 Bradly Farm Rd 1010 S 3rd St, Suite 2A 26 S Main St Tomahawk, WI 54487 Polk City, IA 50226 Albia, IA 52531 715.453.5321 515.984.6001 641.932.2729

2) Minimal Sedation definition - 29.3(3) - (Page 4) – In reviewing the definition of minimal sedation as noted in , section 29.3(3), we believe this not to be consistent with either the 2016 American Dental Association sedation guidelines or the 2018 American Society of Anesthesiologists (ASA) Practice Guidelines for Moderate Procedural Sedation and Analgesia. The latter report was endorsed by the ASA Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology

Rather, the current proposed rule seems to be based on the 2012 ADA guidelines and we would recommend it gets updated to reflect the most recent standards. To that end, we would recommend the following definition:

a. Minimal sedation for adults is limited to a dentist's prescribing or administering a single enteral drug (or in divided doses) that is no more than 1.0 times the maximum recommended dose (MRD) of a drug that can be prescribed for unmonitored home use. A single supplemental dose of the same drug may be administered, provided the supplemental dose is no more than one- half of the initial dose and the dentist does not administer the supplemental dose until the dentist has determined the clinical half-life of the initial dose has passed. b. The total aggregate dose shall not exceed 1.5 times the MRD on the day of treatment.

3) Moderate Sedation Definition (Page 6) – We would advise a similar update to the definition of moderate sedation, as noted below:

29.5(3) the following shall constitute moderate sedation: a. The prescription or administration of a single dose of a single enteral drug in excess of 1.5 the MRD on the day of treatment; b. The combination of more than one enteral drug; c. The administration or prescription of drugs that are not recommended for unmonitored home use; d. The administration of nitrous oxide with more than one enteral drug; and e. The moderate sedation of an ASA category 3-4 patient or a pediatric patient as defined pursuant to subrule 29.4(4)c.

4) Use of Capnography – 29.6(11) - (page 8) – We support the required use of capnography to monitor end-tidal CO2, as mandated by the most recent guidelines as referenced above.

5) Definition of Deep sedation/general anesthesia - 29.7(1) - (Page 9) – We recommend the addition of the word “anesthetic” to complement the word “sedative” when referring to any substance that can produce a controlled state of unconsciousness.

6) Deep sedation/general anesthesia permit holders – 29.9(153) - (page 9) - We would recommend the addition of language to designate a unique area in the office, appropriately

2 equipped, to facilitate safe recovery of patients in circumstances in which deep sedation or general anesthesia was provided.

7) Delegation of moderate sedation and general anesthesia services – 29.10(1) - (page 12) – Similar to our comments on item #1 above, we feel that the reference in the 2nd and 3rd lines to “an anesthesiologist currently licensed by the Iowa Board of Medicine” should be removed and replaced, in the appropriate sections, with a reference to the word, “referral” to show that an anesthesiologist works as an independent provider.

8) Delegation of moderate sedation and general anesthesia services – 29.10(8) - (page 13) - Section 29.10(8) should be amended to include anesthesiologists. “Permit holders and physician anesthesiologists may administer sedation on behalf of another a licensed dentist, who does not hold a sedation permit, provided the permit holder or physician anesthesiologist complies with the following: a. The sedation permit holder or physician anesthesiologist completes a pre-operative evaluation of the patient, and determines the patient is a suitable candidate for sedation; b. The sedation permit holder or physician anesthesiologist administers the administration of the moderate or deep sedation/general anesthesia;

9) Two additional issues for the Board of Dentistry’s consideration: a. In order to best assure for the safe conduct of the anesthetic , we believe that physician anesthesiologists should be able to bring in their own equipment and drugs to a permitted facility, consistent with the medical practice act. The physician anesthesiologist will assume the legal responsibility for the transport of this equipment and therapeutic agents, the selection of which is based upon the education, training, and experience of the physician as well as ASA guidelines.

b. Special consideration should be made for pediatric patients under the age of six years old. The 2018 American Society of Anesthesiologists (ASA) Practice Guidelines for Moderate Procedural Sedation and Analgesia addressed this patient population in the following manner:

“Patients age six (6) and under are unlikely to be able to cooperate with procedures under moderate sedation and may require deep sedation and/general anesthesia. They are at particular risk for respiratory or other complications and have a greater risk of sustaining life-threatening events. Therefore, ASA recommends that all training and protocols should have specific measures for this patient population, including the same standard of care and monitoring for moderate sedation as for deep sedation and general anesthesia, i.e. a distinct and separate qualified anesthesia provider not otherwise involved in the procedure.”

3 Thank you for the opportunity to share our written comments with you.

Sincerely,

Thomas Touney, D.O. President

4 STATE BOARD OF DENTAL EXAMINERS 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701-3942 Phone (512) 463-6400 Fax (5 12) 463-7452

January 4,2017

Mr. Ken Levine Texas Sunset Advisory Commission 1501 North Congress/REJ Building, 6th Floor PO Box 13066 Austin, TX 78711

RE: Report to the Texas Sunset Advisory Commission by the Blue Ribbon Pane) on Dental Anesthesia/Sedation Safety

Dear Mr. Levine;

Enclosed please find the Blue Ribbon Panel on Dental Anesthesia/Sedation Safety's report to the Texas Sunset Advisory Commission.

If I can be of further assistance/ please let me know.

Sincerely, ~i/\l^i/^P(uJu^u Kelly Farmer Executive Hirector

ec: Texas Sunset Advisory Commission Members (w/end.)

Tlic Suit Ouaid orDenfaiEiBniim'redDCTnoKiiscriininatcnnliie basis of ro

Blue Ribbon Panel on Dental Sedation/Anesthesia Safety

of the Texas State Board of Dental Examiners

Panel Members: Ernest B. Luce, D.D.S., Chairman Robert G. McNeill, D.D.S, M.D. David H. Yu, D.D.S., M.S. Reena Kuba, D.D.S., M.S. Bryce S. Chandler, D.D.S. Ronald J. Redden, D.D.S.

January 2017

Agency Contact: Kelly Parker, Executive Director 333 Guadalupe, Tower 3, Suite 800 Austin, TX 78701-3942 Phone (512) 463-6400 Fax [512] 463-7452 Table of Contents Page

Summary of Recommendations i

Full Report

I. Introduction 3

II. Blue Ribbon Panel Membership and Meetings 3

III. Definitions 4

IV. Current Sedation Permit Levels 5

V. Review and Analysis ofDe-identified Data 5 a. Major Events 6 b. Mishaps 6

VI. Summary Comments Regarding Trends In Sedation/Anesthesia 7

VII. Review and Analysis of Dental Rules and Laws in Other States and Anesthesia Related Organizations 10

VIII. Review and Consideration of Scientific Literature 12

IX. Conclusions and Recommendations 14 Clinical Recommendations 15 Administrative Recommendations 16 Administrative Suggestions 17

Appendices Appendix 1 - Texas Administrative Code Appendix 2 - De-identified Data Methodology Report to the Texas Sunset Advisory Commission

Blue Ribbon Panel on Dental Sedation/Anesthesia Safety

of the

Texas State Board of Dental Examiners

January 2017

Summary of Recommendations

The Blue Ribbon Panel on Dental Sedation/Anesthesia Safety (BRP) reviewed de-identified data compiled during board investigations in fiscal years 2012 through 2016 involving patient mortalities and patient harm during or following dental treatment at which sedation/anesthesia was administered and evaluated the appropriate substance and application of emergency protocols related to the administration of sedation/anesthesia.

Panel members, with the assistance of SBDE staff, performed an intensive review of 78 cases. Examination of these 78 cases resulted in the determination that 19 of these events were related to mishandled sedation/anesthesia. BRP identified six of the 19 cases as major events. BRP identified 13 of the 19 cases as mishaps. The panel also reviewed other state laws/rules and scientific literature.

A summary of the BRP recommendations are as follows:

Clinical recommendations:

• SBDE shall have full authority to inspect dental offices where any level of sedation/anesthesia is provided with emphasis on assessing competency of the sedation provider;

• Texas dentists should be required to have written emergency protocols and should be required to document that they practice these protocols with office staff through exercises such as "drills" several times per year;

• The SBDE mandate that at least one support staff member assisting with a sedation procedure (level 2/ 3, 4) receive training in the recognition and management of sedation/anesthesia related emergencies;

• Texas dentists providing moderate/deep/general anesthesia (levels 2, 3, 4) to children under the age of 8 be required to document to the SBDE age specific sedation training; • Texas dentists providing moderate/deep/general anesthesia (levels 2/3/4) to "high risk" patients (age 75 and older, BMI greater than or equal to 30, ASA classification 3, 4} be required to document to the SBDE specific training regarding these groups of patients;

• Offices where portable providers practice be required to have basic ventilation equipment onsite; and.

• Capnography and precordial stethoscope be mandated for level 2, 3 and 4 procedures.

Administrative recommendations:

• The SBDE should establish a standing independent sedation advisory panel to continue to review and advise the SBDE regarding sedation/anesthesia issues;

• The SBDE make public de-identified sedation related major events and mishaps;

• The SBDE collect data regarding sedations performed by Texas dentists, (non- accident data);

• The SBDE create a system to evaluate and approve sedation/anesthesia continuing education;

• The SBDE mandate that the sedation record for a dental procedure be a required part of the dental record/ even if the sedation provider is a non-dentist;

• The SBDE consider creation of a recurrent sedation/anesthesia written examination covering sedation/anesthesia rules; and

• The Texas Legislature make an effort to encourage other state legislatures to share de-identified sedation/anesthesia data publicly.

AdministrativejsuggestJQns:

• The SBDE consider creation of a required online sedation/anesthesia rules examination;

• The SBDE consider encouraging or mandating that dentists use a preoperative sedation checklist; and

• The SBDE consider including more detail En the SBDE rules regarding appropriate pre-operative evaluation and an acceptable sedation/anesthesia record. Report to the Texas Sunset Advisory Commission of the Blue Ribbon Panel on Dental Anesthesia/Sedation Safety Texas State Board of Dental Examiners January 2017

I. Introduction

On August 22, 2016, the Sunset Review Commission directed the Texas State Board of Dental Examiners [SBDE] to establish an independent Blue Ribbon Panel [BRP] to review dental anesthesia-related deaths and mishaps in Texas. On Augusfc 31,2016, SBDE met to establish the BRP, charging the BRP with:

a. reviewing de-identified investigative data related to dental anesthesia- related deaths and mishaps investigated by SBDE between 2011 and 2016; b. reporting on trends and commonalities in the de-identified data; c. reviewing sedation/anesthesia laws, regulations, and studies from other jurisdictions and review relevant published scientific literature; d. opining on whether present laws, regulations, and board policies are sufficient to protect patients; e. recommending appropriate changes to the laws, regulations, and board policies related to the administration of sedation/anesthesia to dental patients in Texas; and f. evaluating emergency protocols.

II. Blue Ribbon Panel Membership and Meetings

The members of the BRP are active sedation providers from various disciplines of dentistry. SBDE selected members of the BRP from its existing dental review panel of licensed Texas dentists who serve as expert reviewers in SBDE s investigations.

The members of the BRP are: * Dr. Bryce Chandler, DDS, general dentist, level 2 provider • Dr. Rena Kuba, DDS, pediatric dentist, level 2 provider • Dr. Ernie Luce, DDS, general dentist, level 3 provider, portable - Chairman • Dr. Robert McNeUL MD, DDS, oral and maxillofacial surgeon/ physician, level 4 provider • Dr. Ronald Redden, DDS, dentist anesthesiologist, level 4 provider, portable • Dr. David Yu, DDS, periodontist, level 3 provider

Three of the members, Drs. Kuba, Luce, and Redden teach sedation/anesthesia in a Texas dental school.

The BRP met in person, in meetings open to the public, on four occasions. BRP member attendance at each of the meetings was 100%. 3 Project Chronology:

22 August, 2016 Sunset Advisory Commission Decision Hearing 31 August, 2016 SBDE open meeting to establish BRP 15 September, 2016 BRP open meeting #1 6 October/ 2016 Staff distributed Master Data Set to BRP [123 cases) 25 October, 2016 BRP open meeting #2 - selected cases (78 cases) 6 November, 2016 Staff distributed detailed data on selected cases (78 cases) 15 November/ 2016 BRP open meeting #3 - identified major events/rnishaps [19 cases) 7 December, 2016 BRP meeting #4 - analyzed data, identified trends and made summary recommendations 4 January, 2017 BRP submitted written report to the Sunset Advisory Commission 11 January, 2017 Sunset Advisory Commission Hearing

III. Definitions

AAOMS - American Association of Oral and Maxillofacial Surgeons

AAPD - American Academy of Pediatric Dentistry

ASDA - American Society of Dentist Anesthesiologists

ASA - American Society ofAnesthesiology

ASA 1, 2, 3, 4, 5 - scale created by the American Society of Anesthesiology to make a general assessment of the physical status of a patient

BMI" body mass index, a measure of obesity based on height and weight

High risk - describes patients who are obese (BMI ^ 30, compromised health [ASA 3 and 4) or elderly [75 years of age or older) IV. Current Sedatlon Permit Levels

The SBDE formally permits Texas dentists to provide different levels of sedation/anesthesia based on educational experience.1 The higher the level of sedation, the greater the educational requirements to obtain that permit. The levels are:

Nitrous oxide/oxygen naughing aas) - typically the lightest level of sedation.

Level 1 sedation (mmiman - a single oral sedative, may be mixed with nitrous oxide, patients become relaxed, but will respond normally to gentle touch. They are very easily awakened.

Level 2 sedation (moderate oral] - multiple oral sedatives are allowed, patients are relaxed but respond purposely to gentle touch. They are easily awakened.

Level 3 sedation (moderate parenteral) - multiple sedatives may be administered by injection [such as an intravenous line). Patients are relaxed but respond purposely to gentle touch, as in level 2. They are easily awakened. level 4 sedation/anesthessa (deep sedation/general anesthesia) - multiple sedatives may be administered by any route, including injection. Patients are "asleep". A painful stimulus must be repeatedly applied to the patient in order to elicit a response, if they respond at all. They are difficult or impossible to wake up with physical stimulation.

V. Review and Analysis of De-identified Data - Major Events and Mishaps

The BRP made an in-depth review of 78 cases investigated by SBDE in search of evidence of mishandled sedation/anesthesia,2 BRP identified six of the 78 cases as major sedation/anesthesia events. BRP identified 13 of the 78 cases as sedation/anesthesia mishaps. Findings were defined as:

a. major events meaning the case resulted in mortality or permanent morbidity and was directly related to mishandled sedation/anesthesia

b. mishaps meaning that an adverse event occurred without permanent injury and was directly related to mishandled sedation/anesthesia

1 See Appendix 1 forSBDE Sedation/Anesthesia rules.

2 Seventy-five of the 78 cases were resolved at the time of review. Three of the 78 cases were under SBDE investigation at the time of BRP review but were incorporated into the BRP review due to their high profile nature and relevance to BRP charge. Major Events - Summary of the Six Major Sedation/Anesthesia Events

Patient Age Health Status S/A Provider Intended Level Outcome adult under 75 obese, cardiac dz Dentist anesth 4,deep IV mortality adult under 75 obese, DM, CV dz Periodontist 3, moderate IV mortality child under 8 healthy General dentist 2, moderate oral brain damage child under 8 healthy Pediatric dentist 2, moderate oral mortality child under 8 cardiac disease MD anesth 4,GA mortality child under 8 healthy MD anesth 4,GA mortality

BRP Findings Regarding the Six Major Sedafcion/Anesthesia Events;

a. Every event involved either young children (child under 8) or adults with high risk factors [obese/compromised health/elderly).

b. Highly trained specialists [including physicians] or a general dentist provided the sedation/anesthesia in each of the major events.

c. For the intended level 2 and 3 events, the patient almost certainly became more deeply sedated than intended. Once deeply sedated, the patient is difficult or impossible to awaken with physical stimulation. It is at this point that breathing becomes compromised. If not recognized and corrected quickly, brain damage or death ensues rapidly.

d. Poor pre-operative evaluation/ drug overdose, not following current monitoring requirements and poor emergency management were also prominent in these cases.

e. Regarding portable providers, a total of four of the major events involved a provider practicing on a portable basis. Two of these four major events involved portable physician anesthesiologists. Being portable did not appear to contribute directly to these major events.

The other two of these four major events involved a portable dentist sedation/anesthesia provider, a level 3 and a level 4 provider. In these two cases/ the provider appeared to not have required emergency equipment that would have been useful in the evolving emergency.

It is unknown how many sedation/anesthetics are performed in Texas on a "portable" basis vs. a "non-porfcable" basis.

Mishaps - Summary of the 13 Sedation/Anesthesia Mishaps

Of the 78 cases studied by BRP, BRP identified 13 cases in which a sedation/anesthesia mishap occurred. Pertinent factors in the mishaps include: a. Eight of the 13 mishaps involved children under 8 or high-risk adults [obese, compromised health or elderly).

b. Dental specialists [oral & maxillofacial surgeons - one case, dentist anesthesiologist - one case, periodontists - two cases and pediatric dentists - three cases) as well as general dentists - six cases, provided the sedation/anesthesla in these cases.

c. The severity of the mishaps ranged from minor to serious.

d. The nature of the mishaps was also quite varied and included drug overdose, premature discharge, predictable but unanticipated drug interaction due to poor drug selection, bolus drug administration (instead of slow, careful, incremental drug administration), and poor management in the early stages of a developing urgency allowing the condition to further deteriorate to an emergent condition and delayed calls to 911.

e. Some of the mishaps occurred in the office while some developed after what was a premature or inappropriate discharge.

f. When an emergency did develop in the office, poor emergency management was present in almost all cases.

g. Every mishap involving a high risk adult patient also involved inadequate or poorly documented pre-procedural patient evaluation and some element of poor sedation technique (such as bolus drug administration, not utilizing required monitors or not being attentive to monitors that were being used while indicating a developing urgency).

VI. Summary Comments Regarding Trends in Sedation/Anesthesia

The SBDE has 16,719 dentists with an active license, and 7,502 licensees hold a Level 1-4 permit. The SBDE has not been required to collect data on each administration of sedation/anesthesia that occurs during dental procedures in Texas (estimated at 500,000 to 1,000,000 administrations per year below). Lacking this detailed information regarding all sedations done in the state limits the statistical conclusions that can be drawn.

However, the BRP was able to study case specific information of actual adverse events that occurred in Texas by reviewing de-identified data collected in board investigations that occurred between 2011 and 2016 involving patient mortalities and patient harm during or following dental treatment at which sedation/anesthesia was administered and evaluated the appropriate substance and application of emergency protocols related to the administration ofsedation/anesthesia. Many level 1, 2, and 3 sedation providers offer sedation on an episodic basis, ranging from only a few times a year to several cases per day. In contrast, most level 4 providers provide sedation/anesthesia multiple times per day. The OMS National Insurance Company (OMSNIC) estimates that the average AAOMS member in Texas performs 669 sedation/anesthetics per year. If each of the approximately 400 OMFS in Texas performs sedation/anesthesia at this rate, approximately 270,000 sedation/anesthetics are performed by Texas OMFS each year.

The American Society of Dentist Anesthesiologists includes 25 members in Texas [also level 4 providers]. Estimates from three of their members suggest that the average dentist anesthesioiogist in Texas treats 435 patients per year suggesting that 10,875 anesthetics are performed annually by Texas Dentist Anesthesiologists.

According to the ADA, there are 659 "professionally active" pediatric dentists in Texas. Anecdotal information among active pediatric dentists suggests that, on average, each of these practitioners performs approximately 200 mlnimal/moderate [mostly level 1 and 2) sedafcions each year. Based on these numbers, it is estimated that Texas Pediatric Dentists perform approximately 130,000 sedatians annually.

Between oral and maxillofacial surgeons, pediatric dentists and dentist anesthesiologists, approximately 411,000 sedation/anesthetics are performed annually in Texas. This group of dentists represents only 1084 of the approximately 7,502 sedation permit holders in the state. Estimating the number of sedation procedures completed by other dentists in Texas [primarily endodontists, periodontists and general dentists) is even more speculative than the estimates above, Likely, the total number of sedation procedures provided by all Texas dentists is somewhere between 500,000 and 1,000,000 annually. For the 5 years of data the BRP evaluated, we estimate between 2,500,000 and 5,000,000 sedation/anesthetic procedures were performed. Five deaths and one brain injury directly related Eo sedation/anesthesia occurred in that time period.

It is important to or keep in mind that patients receiving nitrous oxide/oxygen, level 1 minimal sedation, level 2 or 3 moderate sedation are either awake or easily roused by quiet voice or gentle touch throughout the sedation. Patients receiving level 4 deep sedation/general anesthesia are difficult or impossible to arouse.

By far, the most common proximate cause of morbidity and mortality in sedation is compromised ventilation. Most of the commonly used sedative drugs will depress ventilation in the sedated patient, sometimes to the point that breathing stops completely. When breathing stops or becomes severely limited, the practitioner must recognize this condition, diagnose the specific reason for the compromise and rectify the situation all within a very few minutes. If panic or indecision sets in, emergency equipment/medications are not immediately available, or there is a lack of familiarity with the equipment/medications, or there is a lack of a clearly understood emergency plan, the chance of a poor outcome rises dramatically. Efficient teamwork among the doctor(s) and support staff is essential to help ensure swift resolution of the situation.

8 The margin of safety is narrower in certain specific patient groups. In young children, this time period to manage the evolving crisis is dramatically reduced. Obese individuals also decompensate much faster than slender, healthy adults when breathing becomes compromised. Many medically compromising conditions also result in much more rapid decompensation if breathing stops. Young children and elderly/obese/medically-compromised patients pose extra sedation risks.

Almost without exception, when a mortality occurs associated with minimal or moderate sedation [levels 1, 2, 3), the practitioner allowed the patient to reach a level of deep sedation, where the patient became difficult or impossible to arouse by physical stimulation. It is only at this point that ventilation becomes significantly compromised. Minimal and moderate sedation patients that are kept at a minimal and moderate state do not develop airway compromise. Therefore the root cause of minimal/moderate sedation morbidity/mortality is essentially always that the doctor allowed the patient to become deeply sedated. Preventing the loss of responsiveness will prevent the vast majority of minimal/moderate sedation adverse outcomes. Accomplishing this single goal will have the greatest impact to reduce adverse outcomes in minimal/moderate sedation.

Current SBDE rules require that any patient considered for sedation/anesthesia be ...suitably evaluated prior to the start of any sedative procedure. and go on to state that, "A focused physical evaluation must be performed as deemed appropriate." Every event [major events and mishaps) in our series involving a high-risk patient also involved very poor pre-operative evaluation and limited or no physical evaluation.

Interestingly, among the cases BRP reviewed involving high-risk patients (both major events and mishaps), all of these patients had some sort of medical consultation done prior to the sedation procedure. Lack of medical consultation does not seem to be a factor in the evolution of the mishap or major event in our patients. Data from this patient series does not support the need to mandate enhanced medical consultation.

If the patient becomes more deeply sedated than permitted, current rules require the level 1, 2, and 3 provider to stop the dental procedure and return the patient to the intended level of sedation. The sedation provider is required to continually verify responsiveness and ventilation.

In addition, the current rules mandate that the sedation provider remain in the dental operatory until the patient has reached a defined level of recovery. While unverifiable, there is a strong suspicion that three of the six major events involved the sedation provider leaving the operatory for some period of time while the patient was still sedated, and the crisis developed/evolved during this time period. Leaving a sedated patient unattended is a major contributor to a patient becoming deeply sedated when only minimal or moderate sedation was intended. (The delivery of dental care is stimulating, and this helps keep minimally and moderately sedated patients responsive. If the dental care stops, the stimulation stops and the patient may become unintentionally deeply sedated and possibly stop breathing. If the patient has been left alone, there is no one available in the room to rescue the patient]

Current rules mandate that the dentist have emergency protocols/equipment/medications immediately available in the event of an emergency. Unfortunately, there was a pattern of poor emergency management in the BRP's case reviews: of the 12 cases reviewed where an emergency occurred in the office, emergency management by the dentist was judged to be poor or inadequate in 11 of those cases. The emergency failures observed in fche major events and mishaps involved cases where:

• emergency drugs were available but given in the wrong dose

• emergency ventilation equipment was available, but was used ineffectively

• emergency ventilation equipment was not available

• supplemental oxygen was available but not administered when indicated

• the provider was slow fco activate EMS - (this was the most common finding)

Long delays before activation of the emergency medical system (EMS - 911] were common, but not universal in our cases. For some doctors, making the decision to call 911 represents a personal failure and can become a major obstacle for the doctor to overcome. As the potentially liable individual in the office/ making the call £o summon assistance may, in the eyes of the doctor, open the door to unwanted investigation by a regulatory agency, such as the SBDE, and subsequent fear of punishment. Lack of hands on practice in crisis management likely also contributes to poor performance during an emergency.

For five of the six major events, the sedatlon provider received his/her training in a university/hospital facility versus a continuing education course. For the mishaps, the majority of the providers were trained in a university/hospital setting. The data does not support the concern that dentists trained outside of the university/hospital setting have more sedation accidents.

VII. Review and Analysis of Dental Rules and Laws in other States and Anesthesia Related Organizations

Dental Board of California: Pediatric Anesthesia Study, Draft July 2016 The Dental Board of California undertook a review of pediatric sedation/anesthesia incidents between 2010 and 2015. During this window of time, nine pediatric deaths were noted with various combinations of local anesthesia, sedafcion, and general anesthesia. Fifty-six additional pediatric hospitalizations were also described/ many of which were still being investigated. Limited details are present in the draft report 10 regarding the deaths. Attempting to determine the proximate and root cause of death from the report would be speculative. The draft report includes an extensive review of dental sedation/anesthesia rules/laws in United States. Of note, twenty-five states have special requirements for pediatric patients. Nine states have a separate permit for sedation of pediatric patients. States are not consistent in the way they define a child.

Combined statement of the American Academy of Pediatrics and the American Academy of Pediatric Dentistry: Cote, C] Wilson S. AMERICAN ACADEMY OF PEDIATRICS, AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before^ During and after Sedation for Diagnostic and Therapeutic Procedures: Update. 2016. Pediatrics 20l6;138[l);e20161212

Comments pertinent to BRP s inquiry:

• The use of emergency checklists is recommended.

* A protocol for immediate access to back-up emergency services should be clearly outlined.

• Support staff should be specifically trained to be able to assist with a pediatric emergency.

• All team members should practice emergency protocols periodically.

* In moderate sedation, use of capnography or precordial stethoscope is strongly recommended (required if bidirectional verbal communication not possible].

• In deep sedation, use ofcapnography is required.

American Association of Oral and Maxillofacial Surgeons (AAOMS) - Parameters of Care: Clinical Practice Guidelines for Oral and Maxillofacial Surgery (AAOMS ParCare 2012) - policy requires that, every five years, members undergo an on-site anesthesia office inspection (by AAOMS inspectors) to ensure proper monitoring and emergency equipment is present as well as to review emergency protocols.

California Dental Board in December 2016 adopted new sedation rules for the sedation of children:

• For deep sedation/general anesthesia-Iimitations to operator/anesthetist model of practice.

11 • For moderate sedation - capnography is a required monitor, sedation training equivalent to that of an accredited pediatric dentistry residency, at least one additional staff member trained in Pediatric Advanced Life Support (PALS), for children less than seven years, an additional staff member dedicated to patient monitoring is required.

• (California Legislature and the Governor must approve these rules in order for them to take effect)

October 2016, the American Dental Association (ADA) House of Delegates adopted a resolution to modify their Guidelines for the Use of Sedation and General Anesthesia in Dentistry. In part, this resolution includes a mandate for the use of capnography for patients receiving moderate sedation.

Texas State Board of Dental Examiners' Review of State Dental Boards, determined that 36 of the 50 state dental boards require some sort of dental office inspection, but the details regarding implementation and structure of these inspections vary widely from state to state. Literature regarding the effectiveness of office inspections is described in the next section.

June 2014, the Texas Medical Board adopted a plan to inspect medical offices that provide anesthesia services. [Texas Administrative Code 192.5}

TAG 192.6 allows MDs to request an inspection with a non-binding advisory [for a fee)

Sunset Staff Report 2016-2017: Texas Medical Board-comments regarding medical office inspections where anesthesia is administered. The board currently registers 2/482 physicians who provide office-based anesthesia. [Approximately 7000 Texas dentists have some type ofsedation permit)

Issue 2, key recommendation: "Authorize the board to establish a risk-based approach to its office-based anesthesia inspection, focusing on the length of time since equipment and procedures were last inspected.

Recommendation 2.9 "The board should focus its efforts on the inspection of equipment and office procedures instead of the registered physician to ensure that the inspectors do not waste time re-inspecting equipment approved and procedures." (BRP recommendation will emphasize assessing the competency of the provider if office inspections are implemented)

VIII. Review and Consideration of Scientific Literature

Haynes AB et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. New England Journal of Medicine 2009:360:491-9. This article presents the results from a global study to evaluate the effectiveness of a newly

12 created "checklist" to be used by medical surgical teams prior to the start of a surgical procedure.

Comments pertinent to BRP's inquiry:

• Use of the pre-operative checklist reduced surgicaily related deaths from 1.5% to 0.8% [highly statistically significant).

• Use of the checklist reduced the overall complication rate from 11.0% to 7.0% [highly statistically significant).

Arriaga AF et al. Simulation-Based Trial of Surgical-Crisis Checklists. New England Journal of Medicine 2013;368:246-53. This article details the results of 17 surgical teams participating in 106 simulated surgical-crisis scenarios.

Comment pertinent to BRP's inquiry:

• Use of an emergency checklist reduced "missed steps" from 23% to 6% in these simulated emergencies using high fidelity human simulators

IIgen JS efc ai Technology-enhanced Simulation in Emergency Medicine: A Systematic Review and Meta-Analysis. Academic Emergency Medicine 2013;20:117-127. This article reviews 85 studies, which compare simulation training to conventional training to no intervention at all.

Comment pertinent to BRP's inquiry:

• Simulation based recurrent emergency training was superior to traditional recurrent emergency training and far superior to no recurrent emergency training at all

Shapiro MJ et al. Simulation based teamwork training for emergency department staff: does it improve clinical team performance when added to an existing didactic teamwork curriculum? Quality and Safety in Healthcare 2004;13:417-21. This article reviews the results of a study to determine if adding team training (involving the staff, not just the doctors) would improve team clinical performance.

Comment pertinent to BRP's inquiry:

• Training involving the entire team improved clinical performance of the team

Bhanankar SM et al. Injury and Liability Associated with Monitored Anesthesia Care. Anesthesiology 2006;104:228"34. This article compares closed claims data for monitored anesthesia care (MAC) vs. general anesthesia. Data was abstracted from the Closed Claims database of the American Society of Anesthesiologists. Monitored

13 anesthesia care in the operating room is similar to level 3 moderate parenteral sedation, possibly becoming level 4 deep sedation at times.

Comment pertinent to BRP's inquiry;

• The most common cause of death/injury in MAC was associated with respiratory compromise - ventilation became inadequate during the procedure but was not adequately addressed or managed by the anesthesia provider.

Gaulton TG et al. Administrative issues to ensure safe anesthesia care in the office- based setting. Current Opinion in Anesthesiology 20l3;26:692-697. The authors in this article review the wide variations between states regarding medical office based anesthesia vs. national administrative based structures to regulate office-based anesthesia. They also comment on literature concerning office Inspection/ accreditation and the use of checklists.

Comments pertinent to BRP's inquiry:

• Regarding the effectiveness of office inspections/accreditation: little literature exists to improve outcomes in medicine where office based anesthesia is administered. The few studies available suggest a reduction in complications in accredited facilities, but these studies have also drawn crifcicism concerning methodological limitations. The authors note, "Although the decrease in adverse events did coincide with an increase in practice accreditation, it is impossible to conclude causality/'

• Regarding the use of checklists, the authors present multiple studies all showing that the use of checklists significantly reduce the incidence of complications. The authors were robust in their endorsement of the use of checklists, also noting that federal regulatory agencies such as Centers for Medicaid and Medicare Services (CMS) require the use of surgical safety checklists in their accredited ambulatory surgical centers (ASCs).

IX. Conclusion and Recommendations

The reasons patients die or become permanently disabled in connection with dental care are quite varied. In the BRP case reviews, only a minority of deaths appeared directly related to mishandled sedation/anesthesia. Each of the six major events in this review included at least one significant failure on the part of the sedation provider to follow traditionally accepted core concepts of proper sedation/anesthesia technique. Failures included: poor pre-operative evaluation, poor technique, poor monitoring, and poor emergency management. In fact, all six of the major events included at least two major failures.

14 In the six major events studied by BRP, if current rules had been closely followed and the failures avoided, there likely would have been no sedation related event. Every patient would have been thoroughly evaluated pre-operatively for the planned sedation/anesthetic, drugs would have been conservatively and cautiously administered, and keeping patients closely monitored both electronically and personally by the dentist throughout the procedure. For the minimal and moderate sedation providers, patients would never have become unresponsive. If a truly unpredictable emergency event had occurred, the well-trained and practiced team would have worked together to efficiently manage the situation, including a rapid call to 911 when appropriate.

Unfortunately/ these events did occur and they appear related to failures by the sedation/anesthesia provider at a basic level; poor preparation, poor technique and poor performance when an emergency did occur. It is unclear why practitioners allow this to happen. Equally challenging is to know how to remedy the situation.

The challenge to this panel is to consider whether or not reasonable changes to laws, rules or enforcement will motivate dentists to not be lax, but be meticulously attentive to each step in the sedation/anesthesia process and maintain the highest standard of safety. Rules changes should not limit access to care and should create a regulatory structure to foster best practices in sedation/anesthesia.

The BRP discussed many possible recommendations and suggestions that might be helpful, some clinical in nature, some administrative.

Clinical recommendations:

The SBDE should have the authority to conduct inspections of dentists administering sedation/anesthesia. Thirty-six states have some type of sedation/anesthesia office provider inspection. The BRP suggests any inspections emphasize evaluation of the competency of the dentist.

The SBDE have the authority to review sedation records of level 2, 3 and 4 providers. Determination that the records did not meet the standard of care would be used as an indicator for an on-site office inspection. In the 19 major events/mishaps, there was a strong correlation between poor documentation and poor performance during an office emergency.

The SBDE mandate that sedation providers have written emergency protocols and that they be required to practice these protocols six times per year. Of the cases where an emergency occurred in the office, 11 of 13 mishaps were managed poorly. Literature clearly supports not only the use of emergency protocols [checklists] but also the use of pre-operative checklists. This should include a mechanism to encourage rapid activation of EMS when an emergency occurs and assure adequate access for EMS services.

15 The SBDE mandate that at least one support staff assisting with a sedation procedure (level 2, 3, 4) receive training in the recognition and management of sedation/anesthesia related emergencies. Literature clearly documents that emergency management improves as the entire team is trained as opposed to only the doctor.

The SBDE require level 2, 3, 4 providers who desire to sedate/anesthetize children under 8 years of age to document specific training in the management of this age group of patients.

The SBDE require level 2, 3, 4 providers who desire to sedate/anesthetize high- risk adults (73 years of age and older, ASA 3 or 4, obese - BMI greater than or equal to 30) to document specific training in the management of this group of patients. Each of the major events in this case series involved a child less than 8 years or a high-risk adult,

The SBDE mandate that offices where portable providers function have basic ventilation equipment on-site. Two of the six major events involved a portable provider who attempted to manage an emergency without ventilation equipment.

The SBDE mandate the use ofcapnography and a precordial stethoscope for level 2, 3 and 4 sedation. Of all the potential recommendations discussed by the BRP, this was the only one that did not garner almost immediate and unanimous support. The recommendation passed but with clear reservation by several members. Valid concerns were raised regarding applicability in level 2 and 3 sedation. Literature support for the use of capnography or a precordial stethoscope in deep sedation is well accepted, but is controversial in moderate sedation. Further consideration and study of the issue is needed by an ongoing committee of the board.

Administrative recommendations:

The SBDE continue to utilize an independent panel of expert sedation/anesthesia providers to advise the Board. This BRP was given only a short period of time to accomplish their assigned task. An ongoing group can continue to discuss and more fully evaluate Ideas based on evolving scientific literature that may allow improved patient safety.

The SBDE make public de-identified sedation related major events and mishaps. If other state dental boards would do the same, a much larger pool of information would be available with which to draw better conclusions.

The Texas Legislature make an effort to encourage other state legislatures to share de-identified sedation/anesthesia data publicly. If a majority of states would participate/ a much more scientifically valid pool of data would be available for study. This would include both accident data and non-accident data.

16 The SBDE collect data regarding sedations performed by Texas dentists. (non- accident data)

The SBDE create a system to evaluate and approve sedation/anesthesia continuing education programs.

The SBDE mandate that the sedation record for a dental procedure be a required part of the dental record, even if the sedation provider is a non-dentist.

Administrative suggestions:

The SBDE consider creation of a required online sedation/anesthesia rules examination.

The SBDE consider encouraging or mandating that dentists use a preoperative sedation checklist.

The SBDE consider including more detail in the SBDE rules regarding appropriate pre-operative evaluation and an acceptable sedation/anesthesia record.

17 Review of Texas, Florida and California Sedation Rules

TEXAS Texas Administrative code §110.1 - §110.18) identifies sedation and anesthesia rules as issued by the Texas State Board of Dental Examiners. The rules can be reviewed in their entirety here. The chapters cover rules on Nitrous Oxide/Oxygen Inhalation Sedation, Minimal Sedation, Moderate Sedation, and Deep Sedation or General Anesthesia. The rules are consistent for all levels of sedation regarding supervision. They indicate a dentist shall not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a sedation procedure unless the dentist holds a permit for the sedation procedure being performed. The rules do not speak to the delegation of sedation to other professionals. The rules indicate the dentist must induce the nitrous oxide/oxygen inhalation or administer the sedation and must remain in the room with the patient during the maintenance of the sedation. The rules also state no permit holder shall have more than one person under general anesthesia at the same time exclusive of recovery. Staff requirements are also documented. For example, a dentist administering deep sedation must maintain under continuous direct supervision a minimum of two qualified dental auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of deep sedation and/or general anesthesia. The following are exerts from the rules themselves: 110.3 Nitrous Oxide/Oxygen Inhalation Sedation (b) Standard of Care Requirements. A dentist performing nitrous oxide/oxygen inhalation sedation shall maintain the minimum standard of care for anesthesia, and in addition shall: (4) not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a nitrous oxide/oxygen inhalation sedation procedure unless the dentist holds a permit issued by the Board for the sedation procedure being performed. This provision and similar provisions in subsequent sections address dentists and are not intended to address the scope of practice of persons licensed by any other agency. (4) Monitoring. (A) The dentist must induce the nitrous oxide/oxygen inhalation sedation and must remain in the room with the patient during the maintenance of the sedation until pharmacologic and physiologic vital sign stability is established. (B) After pharmacologic and physiologic vital sign stability has been established, the dentist may delegate the monitoring of the nitrous oxide/oxygen inhalation sedation to a dental auxiliary who has been certified to monitor the administration of nitrous oxide/oxygen inhalation sedation by the State Board of Dental Examiners.

110.4 Minimal Sedation (b) Standard of Care Requirements. A dentist performing minimal sedation shall maintain the minimum standard of care for anesthesia, and in addition shall: (4) not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a minimal sedation procedure unless the dentist holds a permit issued by the Board for the sedation procedure being performed. (4) Monitoring. The dentist administering the sedation must remain in the operatory room to monitor the patient until the patient meets the criteria for discharge to the recovery area. Once the patient meets the criteria for discharge to the recovery area, the dentist may delegate monitoring to a qualified dental auxiliary. 110.5 Moderate Sedation (b) Standard of Care Requirements. A dentist must maintain the minimum standard of care as outlined in §108.7 of this title and in addition shall: (2) maintain under continuous personal supervision auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of moderate sedation; (4) not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a moderate sedation procedure unless the dentist holds a permit issued by the Board for the sedation procedure being performed. 110.6 Deep Sedation or General Anesthesia (b) Standard of Care Requirements. A dentist must maintain the minimum standard of care for the administration of anesthesia as outlined in §108.7 of this title and in addition shall: (2) maintain under continuous direct supervision a minimum of two qualified dental problems, and emergencies incident to the use of deep sedation and/or general anesthesia; (4) not supervise a Certified Registered Nurse Anesthetist (CRNA) performing a deep sedation/general anesthesia procedure unless the dentist holds a permit issued by the Board for the sedation procedure being performed.

110.10 Use of General Anesthetic Agents (c) No permit holder shall have more than one person under general anesthesia at the same time exclusive of recovery.

FLORIDA The Florida Board requires that dentists without an anesthesia permit receive training if delegating sedation. Rules can be found here. The Florida Board of Dentistry allows for physician anesthesiologist to practice anesthesia at any level regardless of the dentist’s level of training with some conditions in place. The Florida Board allows for a dentist to supervise a qualified anesthetist under direct supervision. Dental assistants may monitor Nitrous Oxide inhalation analgesia under the direct supervision of a dentist if conditions are met. The Florida Board also requires that three properly credentialed individuals be present. General anesthesia permit holders are able to perform sedation for dentists that do not have general anesthesia permits, but then both dentists are considered liable. The permitted dentist is also required to remain with the patient from onset until discharge.

64B5-14.0032 Itinerate/Mobile Anesthesia – Physician Anesthesiologist. The level of sedation is not restricted to the level of the permit held by the treating dentist. The level of sedation may be any level necessary for the safe and effective treatment of the patient. A dentist who holds a general anesthesia permit may treat their adult, pediatric, or special needs patients when a physician anesthesiologist performs the sedation services. The following conditions shall apply: (1) General Anesthesia Permit Holders: (a) The physician anesthesiologist performs the administration of the anesthesia and the physician anesthesiologist is responsible for the anesthesia procedure; (b) The dental treatment takes place in the general anesthesia permit holder’s board-inspected and board-registered dental office. (2) Pediatric Moderate Sedation Permit Holders: A pediatric dentist, as recognized by the American Dental Association, who holds a pediatric Moderate sedation permit may treat their pediatric or special needs dental patients when a physician anesthesiologist performs the sedation services. The following conditions shall apply: (a) The physician anesthesiologist performs the administration of the anesthesia, and the physician anesthesiologist is responsible for the anesthesia procedure; (b) The treatment takes place in the permit holder’s board-inspected and board-registered dental office; (c) The dental office meets the supply, equipment, and facility requirements as mandated in Rule 64B5-14.008, F.A.C.; 64B5-14.0034 Itinerate/Mobile Anesthesia – General Anesthesia Permit Holders A general anesthesia permit holder may perform sedation services for a dental patient of another general anesthesia permit holder or moderate or pediatric moderate permit holder in his or her office or another general anesthesia permit holder’s office. In this setting, the following shall apply: (a) The dental treatment may only be performed by a treating dentist who holds a valid anesthesia permit of any level; (b).The treating dentist and the anesthesia provider are both responsible for the adverse incident reporting under Rule 64B5-14.006, F.A.C. (2) Moderate and Pediatric moderate Sedation Permit Holder’s Office: A general anesthesia permit holder may perform sedation services for a dental patient of another dentist who holds a moderate sedation permit or a pediatric moderate sedation permit at the office of the treating dentist. In this setting, the following shall apply: (a) The dental treatment may only be performed by the moderate sedation or pediatric moderate sedation permit holder; (b) The general anesthesia permit holder may perform general anesthesia services once an additional board-inspection establishes that the office complies with the facility, equipment and supply requirements of Rule 64B5-14.008, F.A.C.; (c) The treating dentist and the anesthesia provider are both responsible for the adverse incident reporting requirements under Rule 64B5-14.006, F.A.C. 64B5-14.0036 Treatment of Sedated Patients by Dentists without an Anesthesia Permit. The provisions of this rule control the treatment of patients where an anesthesia permitted dentist sedates the dental patient in his or her board- inspected and board-registered dental office and a Florida licensed dentist without an anesthesia permit performs the dental treatment. (1) The permitted dentist shall perform the sedation in his or her out-patient dental office where the permitted dentist is registered to perform the anesthesia services; (2) The permitted dentist shall remain with the patient from the onset of the performance of the anesthesia until discharge of the patient; (3) The permitted dentist shall have no other patient induced with anesthesia or begin the performance of any other anesthesia services until the patient is discharged; (4) The treating dentist shall have taken a minimum of four hours of continuing education in airway management prior to treating any sedated patient. Two hours must be in didactic training in providing dentistry on sedated patients with compromised airways and two hours must include hands-on training in airway management of sedated patients. After the initial airway management course, the treating dentist shall continue to repeat a minimum of four hours in airway management every four years from the date the course was last taken by the dentist. The continuing education courses taken may be credited toward the mandatory thirty hours of continuing education required for licensure renewal. The requirement that a dentist must first have taken an initial airway management course before treating a sedated patient shall not take effect until March 1, 2014.

64B5-14.0038 Use of a Qualified Anesthetist. In an outpatient dental office, and pursuant to Section 466.002(2), F.S., a dentist may supervise a qualified anesthetist who is administering anesthetic for a dental procedure on a patient of the supervising dentist. The type of supervision required is direct supervision as defined in Section 466.003(8), F.S. In an outpatient dental office, the supervising dentist must have a valid permit for administering sedation to the level of sedation that the qualified anesthetist will be administering to the dental patient during the dental procedure. The dentist must maintain all office equipment and medical supplies required by this chapter to the level of the sedation that the qualified anesthetist will administer to the dental patient.

64B5-14.004 Additional Requirements. After the dentist has induced a patient and established the maintenance level, the assistant or hygienist may monitor the administration of the nitrous-oxide oxygen making only adjustments during this administration and turning it off at the completion of the dental procedure.

CALIFORNIA California rules are more difficult to maneuver, but can be found here. They do not appear to speak directly to supervision or delegation issues, but they do indicate a dentist may order the administration of sedation. The dentist must hold the same level of sedation permit. They also have a separate permit for the administration of sedation to children. This document states that CRNAs can only administer general anesthesia when supervised by a licensed physician or dentist in California.

1647.3. (a) A dentist who desires to administer or order the administration of conscious sedation, shall apply to the board on an application form prescribed by the board. The dentist shall submit an application fee and produce evidence showing that he or she has successfully completed a course of training in conscious sedation that meets the requirements of subdivision

The Attorney General also refused to find a supervision requirement for CRNAs. In its seminal opinion on CRNA scope of practice issued in 1984, the Attorney General determined that CRNAs may administer all forms of anesthesia on the sole condition that anesthesia be “ordered” by a physician, dentist or podiatrist acting within the scope of his or her license. 67 Ops. Att’y. Gen’l. 122, 139 (1984). In reaching this conclusion, the Attorney General overruled a 1972 opinion of its office—56 Ops. Att’y. Gen’l. 1—that held that CRNAs could only administer general anesthesia when supervised by a licensed physician or dentist. The 1984 AG opinion also included an exhaustive review of early case law that suggested physician supervision was required. Review of Other States

Arizona: No training or permit requirements if DDS is delegating sedation to a CRNA or anesthesiologist.

Idaho: Does not require a licensee to obtain a permit if they are outsourcing the sedation. We do have a rule (Use of Other Anesthesia Personnel) which requires the licensee to notify the board if they are using a CRNA, anesthesiologist, or another licensee with a sedation permit.

Louisiana: We have two kinds of sedation permits: personal and office. The personal permit is to confirm that the dentist has the correct post dental school training to give sedation. The office permit is to confirm that the office has the correct equipment, emergency drugs, etc. Both are needed if the dentist is giving the sedation. The dentist is not required to have a personal sedation permit if a CRNA or an anesthesiologist is giving the anesthesia. However, the dentist must have an office permit.

Minnesota: No training or permit requirements if DDS is delegating sedation to a CRNA or anesthesiologist.

Missouri: Requires the dentist to have the permit if the sedation/anesthesia provider is a CRNA. The logic is just as the distinguished gentleman from North Carolina explained, if the dentist is supervising the CRNA, then the dentist should have the appropriate level of training and certification to effectively supervise. The CRNA is an auxiliary and must be under some level of supervision from an MD or a dentist (even a collaborative practice agreement is a level of supervision). If the sedation/anesthesia provider is an MD Anesthesiologist, then the MD is responsible for the sedation, the dentist is not supervising the MD, therefore the dentist does not have to have the permit.

North Carolina: A dentist may “outsource” general anesthesia or sedation services to an MD anesthesiologist without obtaining a permit from the dental board. The MD anesthesiologist is responsible for all equipment, drugs, and inspections. The same is not true with a CRNA. State law requires a CRNA to work under the supervision an MD or dentist. Therefore, in order to supervise a CRNA offering sedation services, the dentist must have a permit appropriate for the level of sedation being offered. Example: if the CRNA is being used to provide moderate sedation, the DDS must have moderate sedation permit as well AND the CRNA may not offer sedation services beyond the level the DDS is allowed to provide. (No general anesthesia if the DDS has a permit for moderate sedation) When hiring a CRNA, the DDS is responsible for all equipment, drugs, permits, inspections, etc.

Oregon: A dentist who does not hold an anesthesia permit may perform dental procedures on a patient who receives anesthesia induced by a physician anesthesiologist licensed by the Oregon Board of Medical Examiners, another Oregon licensed dentist holding an appropriate anesthesia permit, or a Certified Registered Nurse Anesthetist (CRNA) licensed by the Oregon Board of Nursing. A dentist who performs dental procedures on a patient who receives anesthesia induced by a physician anesthesiologist, another dentist holding an anesthesia permit, a CRNA, or a dental hygienist who induces nitrous oxide sedation, shall maintain a current BLS for Healthcare Providers certificate, or its equivalent, and have the same personnel, facilities, equipment and drugs available during the procedure and during recovery as required of a dentist who has a permit for the level of anesthesia being provided.

Tennessee: requires the dentist to have a permit if a CRNA is administering but if another dentists or an anesthesiologists is administering then the dentist is not required to have a permit.

STATE OF IOWA IOWA DENTAL BOARD

KIM REYNOLDS, GOVERNOR JILL STUECKER ADAM GREGG, LT. GOVERNOR EXECUTIVE DIRECTOR

ANESTHESIA CREDENTIALS COMMITTEE Proposed 2019 Meeting Dates

 December 13, 2018 (Thurs) December 14, 2018 (Fri) December 20, 2018 (Thurs)

 February 21, 2019 (Thurs) February 28, 2019 (Thurs) March 7, 2019 (Thurs)

 May 2, 2019 (Thurs) May 3, 2019 (Fri) May 9, 2019 (Thurs)

 June 20, 2019 (Thurs) June 21, 2018 (Fri) June 27, 2019 (Thurs)

 August 29, 2019 (Thurs) August 30, 2019 (Fri) September 5, 2019 (Thurs)

 October 24, 2019 (Thurs) October 25, 2019 (Fri) October 31, 2019 (Thurs)

400 SW 8th STREET, SUITE D, DES MOINES, IA 50309-4687 PHONE:515-281-5157 FAX:515-281-7969 http://www.dentalboard.iowa.gov ADA American Dental Association'

Guidelines for the Use of Sedation and General Anesthesia by Dentists

Adopted by the ADA House of Delegotes, October 2076

l. lntroduction

Theadministrationof local anesthesia,sedationandgeneral anesthesiaisanintegral partofdental practice. The American Dental Association is committed to the safe and effective use of these modalities by appropriately educated and trained dentists. The purpose of these guidelines is to assist dentists in the delivery of safe and effective sedation and anesthesia.

Dentists must comply with their state laws, rules and/or regulations when providing sedation and anesthesia and will only be subject to Section lll. Educational Requirements as required by those state laws, rules and/or regulationsi

Level of sedation is entirely independent of the route of administration. Moderate and deep sedation or general anesthesia may be achieved via any route of administration and thus an appropriately consistent level of training must be established.

For children, the American Dental Association supports the use of the American Academy of Pediatrics/American Academy of Pediatric Dentistry Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.

ll. Definitions Methods of Anxiety and Pain Control minimal sedation (previously known as anxiolysis) - a minimally depressed level of consciousness, produced by a pharmacological method, that retains the patient's ability to independently and continuously maintain an airway and respond normolly to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected.l

Patients whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of minimal sedation.

The following definitions apply to administration of minimal sedation: moximum recommended dose (MRD) - maximum FDA-recommended dose of a drug, as printed in FDA-approved labeling for unmonitored home use. dosing for minimol sedation vio the enterol route - minimal sedation may be achieved by the administration of a drug, either singly or in divided doses, by the enteral route to achieve the desired clinical effect, not to exceed the maximum recommended dose (MRD).

The administration of enteral drugs exceeding the maximum recommended dose during a single appointment is considered to be moderate sedation and the moderate sedation guidelines apply.

Nitrous oxide/oxygen when used in combination with sedative agent(s) may produce minimal, moderate, deep sedation or general anesthesia.

Page 1 of 12 lf more than one enteral drug is administered to achieve the desired sedation effect, with or without the concomitant use of nitrous oxide, the guidelines for moderate sedation must apply.

Note; In accord with this particular definition, the drug(s) and/or techniques used should carry a margin of safety wide enough never to render unintended loss of consciousness. The use of the MRD to guide dosing for minimal sedation is intended to create this margin of safety. moderate sedation - a drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.l

Note: ln accord with this particular definition, the drugs and/or techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely. Repeated dosing of an agent before the effects of previous dosing can be fully appreciated may result in a greater alteration of the state of consciousness than is the intent of the dentist. Further, a patient whose only response is reflex withdrawal from a painful stimulus is not considered to be in a state of moderate sedation.

The following definition applies to the administration of moderate or greater sedation:

titrotion - administration of incremental doses of an intravenous or inhalation drug until a desired effect is reached. Knowledge of each drug's time of onset, peak response and duration of action is essential to avoid over sedation. Although the concept of titration of a drug to effect is critical for patient safety, when the intent is moderate sedation one must know whether the previous dose has taken full effect before administering an additional drug increment. deep sedation - a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.l general anesthesia - a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

Because sedation and general anesthesia are a continuum, it is not always possible to predict how an individual patient will respond. Hence, practitioners intending to produce a given level of sedation should be able to diagnose and manage the physiologic consequences (rescue) for patients whose level of sedation becomes deeper than initially intended.l

For all levels of sedation, the qualified dentist must have the training, skills, drugs and equipment to identify and manage such an occurrence until either assistance arrives (emergency medical service) or the patient returns to the intended level of sedation without airway or cardiovascular complications.

Routes of Administration

enterol- any technique of administration in which the agent is absorbed through the gastrointestinal (Gl) tract or oral mucosa [i.e., oral, rectal, sublingual].

parenterol- a technique of administration in which the drug bypasses the gastrointestinal (Gl) tract [i.e., intramuscular (lM), intravenous (lV), intranasal (lN), submucosal (SM), subcutaneous (SC), intraosseous (lO)1.

Page 2 of 12 transdermol - a technique of administration in which the drug is administered by patch or iontophoresis through ski n.

tronsmucosol- a technique of administration in which the drug is administered across mucosa such as intranasal, sublingual, or rectal.

inholotion - a technique of administration in which a gaseous or volatile agent is introduced into the lungs and whose primary effect is due to absorption through the gas/blood interface.

Terms

anolgesio - the diminution or elimination of pain.

local onesthe-sro - the elimination of sensation, especially pain, in one part of the body by the topical application or regional injection of a drug. Note: Although the use of local anesthetics is the foundation of pain control in dentistry and has a long record of safety, dentists must be aware of the maximum, safe dosage limits for each patient. Large doses of local anesthetics in themselves may result in central nervous system depression, especially in combination with sedative agents.

quolified dentrst - a dentist providing sedation and anesthesia in compliance with their state rules and/or regulations.

operating dentist - dentist with primary responsibility for providing operative dental care while a qualified dentist or independently practicing qualified anesthesia healthcare provider administers minimal, moderate or deep sedation or general anesthesia.

competency - disploying speciol skill or knowledge derived from troining and experience.

must/sholl - indicates an imperative need and/or duty; an essential or indispensable item; mandatory.

should - indicates the recommended manner to obtain the standard; highly desirable.

moy - indicates freedom or liberty to follow a reasonable alternative.

continuol - repeated regularly and frequently in a steady succession.

continuaus - prolonged without any interruption at any time.

time-oriented onesthesia record - documentation at appropriate time intervals of drugs, doses and physiologic data obtained during patient monitoring.

immediotely ovailoble - on site in the facility and available for immediate use.

Page 3 of 12 American Societv of Patient Phvsical Status Classification' Classification Definition Examples, including but not limited to:

ASA I A normal healthy patient Healthy, non-smoking, no or minimal alcohol use ASA II A patient with mild systemic disease Mild diseases only without substantive functional limitations. Examples include (but not Iimited to): current smoker, social alcohol drinker, pregnancy, obesity (30 < BMI < 40), well-controlled DM/HTN, mild luns disease ASA III A patient with severe systemic Substantive functional limitations; One or more disease moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMl >40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, *ESRD undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of Ml, CVA, TlA, or CAD/stents. ASA IV A patient with severe systemic Examples include (but not limited to): recent (< 3 disease that is a constant threat to months) Ml, CVA, TlA, or CAD/stents, ongoing cardiac life ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, DlC, ARD or *ESRD not undersoins reqularlv scheduled dialvsis ASA V A moribund patient who is not Examples include (but not limited to): ruptured expected to survive without the abdominal/thoracic aneurysm, massive trauma, operation intracranial bleed with mass effect, ischemic bowel in the face of significant cardiac pathology or multiple organ/system dysfunction A5A VI A declared brain-dead patient whose organs are being removed for donor ourposes *The addition of "E" denotes Emergency surgery: (An emergency is defined as existing when delay in treatment of the patient would lead to a significant increase in the threat to life or body part)

American Societv of Anesthesioloeists Fastins Gu idelines3 lngested Material Minimum Fastins Period Clear liquids 2 hours Breast milk 4 hours lnfant formula 6 hours Nonhuman milk 6 hours Lieht meal 6 hours Fattv meal 8 hours

lll. Educational Requirements A. Minimal Sedation

1. To administer minimal sedation the dentist must demonstrate competency by having successfully completed:

a. training in minimal sedation consistent with that prescribed in the ADA Guidelines for Teoching Poin Control ond Sedotion to Dentists and Dentol Students,

Page 4 of 12 b. comprehensive training in moderate sedation that satisfies the requirements described in the Moderate Sedation section of the ADA Guidelines for Teaching Poin Control ond Sedotion to Dentists ond Dentol Students at the time training was commenced,

c. an advanced education program accredited by the Commission on Dental Accreditation that affords comprehensive and appropriate training necessary to administer and manage minimal sedation commensurate with these guidelines;

ond

d. a current certification in Basic Life Support for Healthcare Providers.

2. Administration of minimal sedation by another qualified dentist or independently practicing qualified anesthesia healthcare provider requires the operating dentist and his/her clinical staff to maintain current certification in Basic Life Support for Healthcare Providers.

B. Moderate Sedation

1. To administer moderate sedation, the dentist must demonstrate competency by having successfully completed:

a. a comprehensive training program in moderate sedation that satisfies the requirements described in the Moderate Sedation section ofthe ADA GuidelinesforTeaching Poin Control ond Sedotion to Dentists ond Dental Students at the time training was commenced,

b. an advanced education program accredited by the Commission on Dental Accreditation that affords comprehensive and appropriate training necessary to administer and manage moderate sedation commensurate with these guidelines;

ond

c. 1.) A current certification in Basic Life Support for Healthcare Providers and 2) Either current certification in Advanced Cardiac Life Support (ACLS or equivalent) or completion of an appropriate dental sedation/anesthesia emergency management course on the same recertification cycle that is required for ACLS.

2. Administration of moderate sedation by another qualified dentist or independently practicing qualified anesthesia healthcare provider requires the operating dentist and his/her clinical staff to maintain current certification in Basic Life Support for Healthcare Providers.

C. Deep Sedation or General Anesthesia

1. To administer deep sedation or general anesthesia, the dentist must demonstrate competency by having completed:

a. An advanced education program accredited by the Commission on Dental Accreditation that affords comprehensive and appropriate training necessary to administer and manage deep sedation or general anesthesia, commensurate with Part lV.C of these guidelines;

ond

Page 5 of 12 b. 1) A current certification in Basic Life Support for Healthcare Providers and 2) either current certificbtion in Advanced Cardiac Life Support (ACLS or equivalent) or completion of an appropriate dental sedation/anesthesia emergency management course on the same re-certification cycle that is required for ACLS.

2. Administration of deep sedation or general anesthesia by another qualified dentist or independently practicing qualified anesthesia healthcare provider requires the operating dentist and his/her clinical staff to maintain current certification in Basic Life Support (BLS) Course for the Healthcare Provider.

lV. Clinical Guidelines A. Minimal sedation

1. Patient History and Evaluation

Patients considered for minimal sedation must be suitably evaluated prior to the start of any sedative procedure. ln healthy or medically stable individuals (ASA l, ll) this should consist of a review of their current medical history and medication use. In addition, patients with significant medical considerations (ASA lll, lV) may require consultation with their primary care physician or consulting medical specialist.

2. Pre-Operative Evaluation and Preparation

The patient, parent, legal guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained. Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed. a An appropriate focused physical evaluation should be performed. a Baseline vital signs including body weight, height, blood pressure, pulse rate, and respiration rate must be obtained unless invalidated by the nature of the patient, procedure or equipment. Body temperature should be measured when clinically indicated. a Preoperative dietary restrictions must be considered based on the sedative technique prescribed. a Pre-operative verbal and written instructions must be given to the patient, parent, escort, legal guardian or care giver.

3. Personnel and Equipment Requirements

Person nel: r At least one additional person trained in Basic Life Support for Healthcare Providers must be present in addition to the dentist.

Equipment:

A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available. Documentation of compliance with manufacturers' recommended maintenance of monitors, anesthesia delivery systems, and other anesthesia-related equipment should be maintained. A pre-procedural check of equipment for each administration of sedation must be performed. When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either (1) a functioning device that prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm. An appropriate scavenging system must be available if gases other than oxygen or air are used.

Page 6 of 12 4. Monitoring and Documentation

Monitoring: A dentist, or at the dentist's direction, an appropriately trained individual, must remain in the operatory during active dental treatment to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:

Consciousness: o Level of sedation (e.g., responsiveness to verbal commands) must be continually assessed.

Oxygenation:

. Oxygen saturation by pulse oximetry may be clinically useful and should be considered.

Ventilation:

o The dentist and/or appropriately trained individual must observe chest excursions. o The dentist andlor appropriately trained individual must verify respirations.

Circulation: o Blood pressure and heart rate should be evaluated pre-operatively, post-operatively and intraoperatively as necessary (unless the patient is unable to tolerate such monitoring).

Documentation: An appropriate sedative record must be maintained, including the names of all drugs administered, time administered and route of administration, including local anesthetics, dosages, and monitored physiological parameters.

5. Recovery and Discharge

. Oxygen and suction equipment must be immediately available if a separate recovery area is utilized. r The qualified dentist or appropriately trained clinical staff must monitor the patient during recovery until the patient is ready for discharge by the dentist. o The qualified dentist must determine and document that level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge. o Post-operative verbal and written instructions must be given to the patient, parent, escort, legal guardian or care giver.

6. Emergency Management

r lf a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient returns is returned to the intended level of sedation. e The qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of minimal sedation and providing the equipment and protocols for patient rescue.

B. Moderate Sedation

1. Patient History and Evaluation

Patients considered for moderate sedation must undergo an evaluation prior to the administration of any sedative. This should consist of at least a review at an appropriate time of their medical history and

PageT of 12 medication use and NPO (nothing by mouth) status. ln addition, patients with significant medical considerations (e.g., ASA lll, lV) should also require consultation with their primary care physician or consulting medical specialist. Assessment of Body Mass lndex (BMl)a should be considered part of a pre- procedural workup. Patients with elevated BMI may be at increased risk for airway associated morbidity, particularly if in association with other factors such as obstructive sleep apnea. 2. Pre-operative Evaluation and Preparation

The patient, parent, legal guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained. Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed. a An appropriate focused physical evaluation must be performed. a Baseline vital signs including body weight, height, blood pressure, pulse rate, respiration rate, and blood oxygen saturation by pulse oximetry must be obtained unless precluded by the nature of the patient, procedure or equipment. Body temperature should be measured when clinically indicated. Pre-operative verbal or written instructions must be given to the patient, parent, escort, legal guardian or care giver, including pre-operative fasting instructions based on the ASA Summary of Fasting and Pharmacologic Recommendations.

3. Personnel and Equipment Requirements

Personnel: o At least one additional person trained in Basic Life Support for Healthcare Providers must be present in addition to the dentist.

Equipment:

A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available. Documentation of compliance with manufacturers' recommended maintenance of monitors, anesthesia delivery systems, and other anesthesia-related equipment should be maintained. A pre-procedural check of equipment for each administration of sedation must be performed. When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either (1) a functioning device that prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm. The equipment necessary for monitoring end-tidal COz and auscultation of breath sounds must be immediately available. a An appropriate scavenging system must be available if gases other than oxygen or air are used. a The equipment necessary to establish intravascular or intraosseous access should be available until the patient meets discharge criteria.

4. Monitoring and Documentation

Monitoring: A qualified dentist administering moderate sedation must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. When active treatment concludes and the patient recovers to a minimally sedated level a qualified auxiliary may be directed bythe dentist to remain with the patient and continue to monitorthem as explained in the guidelines until they are discharged from the facility. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility. Monitoring must include:

Page 8 of 12 Consciousness: e Level of sedation (e.g., responsiveness to verbal command) must be continually assessed.

Oxygenation:

. Oxygen saturation must be evaluated by pulse oximetry continuously.

Ventilation: o The dentist must observe chest excursions continually. o The dentist must monitor ventilation and/or breathing by monitoring end-tidal COz unless precluded or invalidated by the nature of the patient, procedure or equipment. In addition, ventilation should be monitored by continual observation of qualitative signs, including auscultation of breath sounds with a precordial or pretracheal stethoscope.

Circulation:

o The dentist must continually evaluate blood pressure and heart rate unless invalidated by the nature of the patient, procedure or equipment and this is noted in the time-oriented anesthesia record. o Continuous ECG monitoring of patients with significant cardiovascular disease should be considered.

Documentation:

o Appropriate time-oriented anesthetic record must be maintained, including the names of all drugs, dosages and their administration times, including local anesthetics, dosages and monitored physiological parameters. o Pulse oximetry, heart rate, respiratory rate, blood pressure and level of consciousness must be recorded continually.

5. Recovery and Discharge

. Oxygen and suction equipment must be immediately available if a separate recovery area is utilized. o The qualified dentist or appropriately trained clinical staff must continually monitor the patient's blood pressure, heart rate, oxygenation and level of consciousness. o The qualified dentist must determine and document that level of consciousness; oxygenation, ventilation and circulation are satisfactory for discharge. o Post-operative verbal and written instructions must be given to the patient, parent, escort, legal guardian or care giver. ' o lf a pharmacological reversal agent is administered before discharge criteria have been met, the patient must be monitored for a longer p.eriod than usual before discharge, since re-sedation may occur once the effects of the reversal agent have waned.

6. Emergenry Management

o lf a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient is returned to the intended level ofsedation. o The qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of moderate sedation and providing the equipment, drugs and protocol for patient rescue.

Page 9 of 12 C. Deep Sedation or Genera! Anesthesia

1. Patient History and Evaluation

Patients considered for deep sedation or general anesthesia must undergo an evaluation prior to the administration of any sedative. This must consist of at least a review of their medical history and medication use and NPO (nothing by mouth) status. ln addition, patients with significant medical considerations (e.g., ASA lll, lV) should also require consultation with their primary care physician or consulting medical specialist. Assessment of Body Mass lndex (BMl)a should be considered part of a pre-procedural workup. Patients with elevated BMI may be at increased risk for airway associated morbidity, particularly if in association with other factors such as obstructive sleep apnea.

2. Pre-operative Evaluation and Preparation

r The patient, parent, legal guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative or anesthetic agents and informed consent for the proposed sedation/anesthesia must be obtained. o Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed. o A focused physical evaluation must be performed as deemed appropriate. o Baseline vital signs including body weight, height, blood pressure, pulse rate, respiration rate, and blood oxygen saturation by pulse oximetry must be obtained unless invalidated by the patient, procedure or equipment. In addition, body temperature should be measured when clinically appropriate. o Pre-operative verbal and written instructions must be given to the patient, parent, escort, legal guardian or care giver, including pre-operative fasting instructions based on the ASA Summary of Fasting and Pha rmacol ogic Recommendations. o An intravenous line, which is secured throughout the procedure, must be established except as provided in part lV. C.6. Special Needs Patients.

3. Personnel and Equipment Requirements

Personnel: A minimum of three (3) individuals must be present.

A dentist qualified in accordance with part lll. C. of these Guidelines to administer the deep sedation or general anesthesia. Two additional individuals who have current certification of successfully completing a Basic Life Support (BLS) Course for the Healthcare Provider. When the same individual administering the deep sedation or general anesthesia is performing the dental procedure, one of the additional appropriately trained team members must be designated for patient monitoring.

Equipment:

Page l0 of 12 . An appropriate scavenging system must be available ifgases other than oxygen or air are used. o The equipment necessary to establish intravenous access must be available. o Equipment and drugs necessary to provide advanced airway management, and advanced cardiac life support must be immediately available. o The equipment necessary for monitoring end-tidal COz and auscultation of breath sounds must be immediately available. o Resuscitation medications and an appropriate defibrillator must be immediately available.

4. Monitoring and Documentation

Monitoring: A qualified dentist administering deep sedation or general anesthesia must remain in the operatory room to monitor the patient continuously until the patient meets the criteria for recovery. The dentist must not leave the facility until the patient meets the criteria for discharge and is discharged from the facility. Monitoring must include:

Oxygenation: . Oxygenation saturation must be evaluated continuously by pulse oximetry.

Ventilation: r lntubated patient: End-tidal COz must be continuously monitored and evaluated. o Non-intubated patient: End-tidal COz must be continually monitored and evaluated unless precluded or invalidatedbythenatureofthepatient,procedure,orequipment. lnaddition,ventilationshouldbe monitored and evaluated by continual observation of qualitative signs, including auscultation of breath sounds with a precordial or pretracheal stethoscope. o Respiration rate must be continually monitored and evaluated.

Circulation: o The dentist must continuously evaluate heart rate and rhythm via ECG throughout the procedure, as well as pulse rate via pulse oximetry. e The dentist must continually evaluate blood pressure.

Temperature: o A device capable of measuring body temperature must be readily available during the administration of deep sedation or general anesthesia. . The equipment to continuously monitor body temperature should be available and must be performed whenever triggering agents associated with malignant hyperthermia are administered.

Documentation: . Appropriate time-oriented anesthetic record must be maintained, including the names of all drugs, dosages and their administration times, in'cluding local anesthetics and monitored physiological parameters. o Pulse oximetry and end-tidal COz measurements (if taken), heart rate, respiratory rate and blood pressure must be recorded continually.

5. Recovery and Discharge

. Oxygen and suction equipment must be immediately available if a separate recovery area is utilized. r The dentist or clinical staff must continually monitor the patient's blood pressure, heart rate, oxygenation and level of consciousness. . The dentist must determine and document that level of consciousness; oxygenation, ventilation and circulation are satisfactory for discharge.

Page 11 of 12 Post-operative verbal and written instructions must be given to the patientT and parent, escort, guardian or care giver.

6. Special Needs Patients

Because many dental patients undergoing deep sedation or general anesthesia are mentally and/or physically challenged, it is not always possible to have a comprehensive physical examination or appropriate laboratory tests prior to administering care. When these situations occur, the dentist responsible for administering the deep sedation or general anesthesia should document the reasons preventing the recommended preoperative management.

ln selected circumstances, deep sedation or general anesthesia may be utilized without establishing an indwelling intravenous line. These selected circumstances may include very brief procedures or periods of time, which, for example, may occur in some patients; or the establishment of intravenous access after deep sedation or general anesthesia has been induced because of poor patient cooperation.

7. Emergency Management

The qualified dentist is responsible for sedative/anesthetic management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of deep sedation or general anesthesia and providing the equipment, drugs and protocols for patient rescue.

1 Excerpted from Continuum of Depth of Sedation: Definition of Genenl Anesthesia and Levels of Sedation/Analgesia, 2014, of the Ameican Society of Anesthesiologists (ASA) 2 ASA PhysicalSfafus C/assfibation System is reprinted with permission of the Ameican Society of Anesfhestb/ogtsts, Updated by ASA House of Delegates, October 15, 2014. 3 Ameican Society of Anesfresio/og,sfsi Practice Guidelines for preoperative fasting and the use of pharmacologic agents to reduce the isk of pulmonary aspiration: application to heafthy patients undergoing elective procedures. Anesthesiology 114:495. 2011. Repinted with permission. 4 Standardized BMI category definitions can be obtained from the Centers for Disease C or theAmeljgal$odgfi-of. Anestheslo/oqlsts.

Page L2 of 12 CLINICAL REPORT Guidance for the Clinician in Rendering Pediatric Care

Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016 Charles J. Coté, MD, FAAP, Stephen Wilson, DMD, MA, PhD , AMERICAN ACADEMY OF PEDIATRICS, AMERICAN ACADEMY OF PEDIATRIC DENTISTRY

The safe sedation of children for procedures requires a systematic abstract approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful This document is copyrighted and is property of the American presedation evaluation for underlying medical or surgical conditions Academy of Pediatrics and its Board of Directors. All authors have that would place the child at increased risk from sedating medications, fi led confl ict of interest statements with the American Academy of Pediatrics. Any confl icts have been resolved through a process appropriate fasting for elective procedures and a balance between the approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial depth of sedation and risk for those who are unable to fast because of the involvement in the development of the content of this publication. urgent nature of the procedure, a focused airway examination for large Clinical reports from the American Academy of Pediatrics benefi t from (kissing) tonsils or anatomic airway abnormalities that might increase the expertise and resources of liaisons and internal (AAP) and external reviewers. However, clinical reports from the American Academy of potential for airway obstruction, a clear understanding of the medication’s Pediatrics may not refl ect the views of the liaisons or the organizations pharmacokinetic and pharmacodynamic effects and drug interactions, or government agencies that they represent. appropriate training and skills in airway management to allow rescue of The guidance in this report does not indicate an exclusive course of treatment or serve as a standard of medical/dental care. Variations, the patient, age- and size-appropriate equipment for airway management taking into account individual circumstances, may be appropriate. and venous access, appropriate medications and reversal agents, suffi cient All clinical reports from the American Academy of Pediatrics numbers of staff to both carry out the procedure and monitor the patient, automatically expire 5 years after publication unless reaffi rmed, appropriate physiologic monitoring during and after the procedure, a revised, or retired at or before that time. properly equipped and staffed recovery area, recovery to the presedation DOI: 10.1542/peds.2016-1212 level of consciousness before discharge from medical/dental supervision, PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). and appropriate discharge instructions. This report was developed Copyright © 2016 American Academy of Pediatric Dentistry and American Academy of Pediatrics. This report is being published concurrently in through a collaborative effort of the American Academy of Pediatrics and Pediatric Dentistry July 2016. The articles are identical. Either citation the American Academy of Pediatric Dentistry to offer pediatric providers can be used when citing this report. updated information and guidance in delivering safe sedation to children. To cite: Coté CJ, Wilson S, AMERICAN ACADEMY OF PEDIATRICS, AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016; 138(1):e20161212

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 :e 20161212 FROM THE AMERICAN ACADEMY OF PEDIATRICS INTRODUCTION responsible practitioner. Although the procedure allow for the accurate The number of diagnostic and minor intended to encourage high-quality and rapid diagnosis of complications surgical procedures performed on patient care, adherence to the and initiation of appropriate rescue 44,63, 64, 67, 68, 74, 90, 96, 110, 159–174 pediatric patients outside of the recommendations in this document interventions. traditional operating room setting cannot guarantee a specific patient The work of the Pediatric Sedation has increased in the past several outcome. However, structured Research Consortium has improved decades. As a consequence of this sedation protocols designed to the sedation knowledge base, change and the increased awareness incorporate these safety principles demonstrating the marked safety of of the importance of providing have been widely implemented and sedation by highly motivated and 11, 23, 24, 27, analgesia and anxiolysis, the need for shown to reduce morbidity. skilled practitioners from a variety 30–33, 35, 39, 41, 44, 47, 51, 74–84 sedation for procedures in physicians’ These practice of specialties practicing the above offices, dental offices, subspecialty recommendations are proffered modalities and skills that focus on a 45,83, 95, 128–138 procedure suites, imaging facilities, with the awareness that, regardless culture of sedation safety. emergency departments, other of the intended level of sedation However, these groundbreaking inpatient hospital settings, and or route of drug administration, studies also show a low but ambulatory surgery centers also the sedation of a pediatric patient persistent rate of potential sedation- has increased markedly.1–52 In represents a continuum and may induced life-threatening events, recognition of this need for both result in respiratory depression, such as apnea, airway obstruction, elective and emergency use of laryngospasm, impaired airway laryngospasm, pulmonary aspiration, sedation in nontraditional settings, patency, apnea, loss of the patient’s desaturation, and others, even when the American Academy of Pediatrics protective airway reflexes, and the sedation is provided under the 38, 43, 45, 47, 48, (AAP) and the American Academy cardiovascular instability. direction of a motivated team of 59, 62, 63, 85–112 129 of Pediatric Dentistry (AAPD) have specialists. These studies have published a series of guidelines for helped define the skills needed to the monitoring and management of Procedural sedation of pediatric rescue children experiencing adverse pediatric patients during and after patients has serious associated sedation events. 2, 5, 38, 43, 45, 47, 48, 62, 63, 71, 83, 85, 88–105, sedation for a procedure.53–58 The risks. 107–138 purpose of this updated report is to These adverse responses The sedation of children is different unify the guidelines for sedation used during and after sedation for a from the sedation of adults. Sedation by medical and dental practitioners; diagnostic or therapeutic procedure in children is often administered to to add clarifications regarding may be minimized, but not relieve pain and anxiety as well as to monitoring modalities, particularly completely eliminated, by a careful modify behavior (eg, immobility) so regarding continuous expired carbon preprocedure review of the patient’s as to allow the safe completion of a dioxide measurement; to provide underlying medical conditions and procedure. A child’s ability to control updated information from the medical consideration of how the sedation his or her own behavior to cooperate and dental literature; and to suggest process might affect or be affected for a procedure depends both on his methods for further improvement in by these conditions: for example, or her chronologic age and cognitive/ safety and outcomes. This document children with developmental emotional development. Many brief uses the same language to define disabilities have been shown to have procedures, such as suture of a minor sedation categories and expected a threefold increased incidence of laceration, may be accomplished physiologic responses as The Joint desaturation compared with with distraction and guided imagery Commission, the American Society children without developmental techniques, along with the use 74, 78, 103 of Anesthesiologists (ASA), and the disabilities. Appropriate drug of topical/local anesthetics and 175–181 AAPD.56,57, 59–61 selection for the intended procedure, minimal sedation, if needed. a clear understanding of the sedating However, longer procedures that medication’s pharmacokinetics require immobility involving children This revised statement reflects and pharmacodynamics and drug younger than 6 years or those with the current understanding of interactions, as well as the presence developmental delay often require an appropriate monitoring needs of of an individual with the skills increased depth of sedation to gain pediatric patients both during and needed to rescue a patient from control of their behavior.86, 87, 103 after sedation for a procedure.3,4, 11, an adverse response are critical.42, Children younger than 6 years 18, 20, 21, 23, 24, 33, 39, 41, 44, 47, 51, 62–73, The 48, 62, 63, 92, 97, 99, 125–127, 132, 133, 139–158 (particularly those younger than 6 monitoring and care outlined Appropriate physiologic monitoring months) may be at greatest risk of may be exceeded at any time on and continuous observation by an adverse event.129 Children in this the basis of the judgment of the personnel not directly involved with age group are particularly vulnerable

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e2 FROM THE AMERICAN ACADEMY OF PEDIATRICS EMS arrival.63, 214 Rescue techniques require specific training and skills.63, 74, 215, 216 The maintenance of the skills needed to rescue a child with apnea, laryngospasm, and/or airway obstruction include the ability to open the airway, suction secretions, provide continuous positive airway pressure (CPAP), perform successful bag-valve-mask ventilation, insert an oral airway, a nasopharyngeal airway, or a laryngeal mask airway (LMA), and, rarely, perform tracheal intubation. These skills are likely best maintained with frequent simulation and team training for the management of rare events.128, 130, 217–220 Competency with emergency airway management procedure algorithms is fundamental FIGURE 1 for safe sedation practice and Suggested management of airway obstruction. successful patient rescue (see Figs 1, 2, and 3).215, 216, 221–223 to the sedating medication’s effects intended level of sedation is “deep,” on respiratory drive, airway patency, practitioners must have the skills Practitioners should have an and protective airway reflexes.62, 63 to rescue from a state of “general in-depth knowledge of the Other modalities, such as careful anesthesia.” The ability to rescue agents they intend to use and preparation, parental presence, means that practitioners must be their potential complications. A hypnosis, distraction, topical local able to recognize the various levels number of reviews and handbooks anesthetics, electronic devices with of sedation and have the skills and age-appropriate games or videos, age- and size-appropriate equipment for sedating pediatric patients are 30, 39, 65, 75, 171, 172, 201, 224–233 guided imagery, and the techniques necessary to provide appropriate available. advised by child life specialists, may cardiopulmonary support if needed. There are specific situations that are reduce the need for or the needed beyond the scope of this document. These guidelines are intended depth of pharmacologic Specifically, guidelines for the for all venues in which sedation sedation.29, 46, 49, 182–211 delivery of general anesthesia and for a procedure might be monitored anesthesia care (sedation Studies have shown that it is performed (hospital, surgical or analgesia), outside or within the common for children to pass from center, freestanding imaging operating room by anesthesiologists the intended level of sedation to facility, dental facility, or private or other practitioners functioning a deeper, unintended level of office). Sedation and anesthesia within a department of sedation, 85, 88, 212, 213 making the in a nonhospital environment (eg, anesthesiology, are addressed concept of rescue essential to safe private physician’s or dental office, sedation. Practitioners of sedation freestanding imaging facility) by policies developed by the ASA must have the skills to rescue the historically have been associated and by individual departments 234 patient from a deeper level than with an increased incidence of of anesthesiology. In addition, that intended for the procedure. “failure to rescue” from adverse guidelines for the sedation of patients For example, if the intended level of events, because these settings may undergoing mechanical ventilation sedation is “minimal,” practitioners lack immediately available backup. in a critical care environment or must be able to rescue from Immediate activation of emergency for providing analgesia for patients “moderate sedation”; if the intended medical services (EMS) may be postoperatively, patients with level of sedation is “moderate,” required in such settings, but the chronic painful conditions, and practitioners must have the skills to practitioner is responsible for life- patients in hospice care are beyond rescue from “deep sedation”; if the support measures while awaiting the scope of this document.

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e3 anxiety, minimize psychological trauma, and maximize the potential for amnesia; (4) to modify behavior and/or movement so as to allow the safe completion of the procedure; and (5) to return the patient to a state in which discharge from medical/dental supervision is safe, as determined by recognized criteria (Supplemental Appendix 1). These goals can best be achieved by selecting the lowest dose of drug with the highest therapeutic index for the procedure. It is beyond the scope of this document to specify which drugs are appropriate for which procedures; however, the selection of the fewest number of FIGURE 2 drugs and matching drug selection to Suggested management of laryngospasm. the type and goals of the procedure are essential for safe practice. For example, analgesic medications, such as opioids or ketamine, are indicated for painful procedures. For nonpainful procedures, such as computed tomography or magnetic resonance imaging (MRI), sedatives/ hypnotics are preferred. When both sedation and analgesia are desirable (eg, fracture reduction), either single agents with analgesic/sedative properties or combination regimens are commonly used. Anxiolysis and amnesia are additional goals that should be considered in the selection of agents for particular patients. However, the potential for an adverse outcome may be increased when 2 or more sedating medications are administered.62, 127, 136, 173, 235 Recently, there has been renewed interest in noninvasive routes of medication administration, including intranasal and inhaled routes (eg, nitrous oxide; see below).236 Knowledge of each drug’s time of onset, peak response, and duration FIGURE 3 of action is important (eg, the Suggested management of apnea. peak electroencephalogram [EEG] effect of intravenous midazolam GOALS OF SEDATION procedures are as follows: (1) occurs at ∼4.8 minutes, compared to guard the patient’s safety and with that of diazepam at ∼1.6 The goals of sedation in the pediatric welfare; (2) to minimize physical minutes237–239). Titration of drug patient for diagnostic and therapeutic discomfort and pain; (3) to control to effect is an important concept;

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e4 FROM THE AMERICAN ACADEMY OF PEDIATRICS one must know whether the appropriate subspecialists and/ provide initial rescue for life- previous dose has taken full effect or an anesthesiologist for patients threatening complications. before administering additional at increased risk of experiencing drugs.237 Drugs that have a long adverse sedation events because of On-site Monitoring, Rescue Drugs, duration of action (eg, intramuscular their underlying medical/surgical and Equipment pentobarbital, phenothiazines) conditions. An emergency cart or kit must be have fallen out of favor because immediately accessible. This cart or of unpredictable responses and Responsible Person kit must contain the necessary age- prolonged recovery. The use of The pediatric patient shall be and size-appropriate equipment (oral these drugs requires a longer period accompanied to and from the and nasal airways, bag-valve-mask of observation even after the child treatment facility by a parent, legal device, LMAs or other supraglottic achieves currently used recovery guardian, or other responsible devices, laryngoscope blades, 62, 238–241 and discharge criteria. person. It is preferable to have tracheal tubes, face masks, blood This concept is particularly 2 adults accompany children pressure cuffs, intravenous catheters, important for infants and toddlers who are still in car safety seats etc) to resuscitate a nonbreathing transported in car safety seats; if transportation to and from a and unconscious child. The contents re-sedation after discharge treatment facility is provided by 1 of of the kit must allow for the provision attributable to residual prolonged the adults.250 of continuous life support while the drug effects may lead to airway patient is being transported to a obstruction.62, 63, 242 In particular, Facilities medical/dental facility or to another promethazine (Phenergan; Wyeth area within the facility. All equipment Pharmaceuticals, Philadelphia, The practitioner who uses sedation and drugs must be checked and PA) has a “black box warning” must have immediately available maintained on a scheduled basis regarding fatal respiratory facilities, personnel, and equipment (see Supplemental Appendices depression in children younger to manage emergency and rescue 3 and 4 for suggested drugs and than 2 years.243 Although the liquid situations. The most common emergency life support equipment formulation of chloral hydrate is serious complications of sedation to consider before the need for no longer commercially available, involve compromise of the airway or rescue occurs). Monitoring devices, some hospital pharmacies now depressed respirations resulting in such as electrocardiography (ECG) are compounding their own airway obstruction, hypoventilation, machines, pulse oximeters with size- formulations. Low-dose chloral laryngospasm, hypoxemia, and apnea. appropriate probes, end-tidal carbon hydrate (10–25 mg/kg), in Hypotension and cardiopulmonary dioxide monitors, and defibrillators combination with other sedating arrest may occur, usually from with size-appropriate patches/ medications, is used commonly in the inadequate recognition paddles, must have a safety and pediatric dental practice. and treatment of respiratory function check on a regular basis as 42, 48, 92, 97, 99, 125, 132, 139–155, compromise. required by local or state regulation. Other rare complications also may The use of emergency checklists is GENERAL GUIDELINES include seizures, vomiting, and recommended, and these should be allergic reactions. Facilities providing immediately available at all sedation Candidates pediatric sedation should monitor locations; they can be obtained from Patients who are in ASA classes I for, and be prepared to treat, such http:// www. pedsanesthesia. org/ . and II are frequently considered complications. appropriate candidates for Documentation Back-up Emergency Services minimal, moderate, or deep sedation Documentation prior to sedation (Supplemental Appendix 2). A protocol for immediate access shall include, but not be limited to, Children in ASA classes III and to back-up emergency services the following recommendations: IV, children with special needs, shall be clearly outlined. For and those with anatomic airway nonhospital facilities, a protocol 1. Informed consent: The patient abnormalities or moderate to severe for the immediate activation of the record shall document that tonsillar hypertrophy present EMS system for life-threatening appropriate informed consent issues that require additional complications must be established was obtained according to and individual consideration, and maintained.44 It should be local, state, and institutional 251, 252 particularly for moderate and deep understood that the availability requirements. sedation.68, 244–249 Practitioners of EMS does not replace the 2. Instructions and information are encouraged to consult with practitioner’s responsibility to provided to the responsible

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e5 person: The practitioner shall evaluate preceding food and fluid to administer deep sedation to a provide verbal and/or written intake before administering sedation. child with a minor condition who instructions to the responsible It is likely that the risk of aspiration just ate a large meal; conversely, person. Information shall during procedural sedation differs it is not justifiable to withhold include objectives of the sedation from that during general anesthesia sedation/analgesia from the child and anticipated changes in involving tracheal intubation or in significant pain from a displaced behavior during and after other airway manipulations.259, 260 fracture who had a small snack a few sedation.163, 253–255 Special However, the absolute risk of hours earlier. Several emergency instructions shall be given aspiration during elective procedural department studies have reported a to the adult responsible for sedation is not yet known; the reported low to zero incidence of pulmonary infants and toddlers who will incidence varies from ∼1 in 825 to ∼1 aspiration despite variable fasting be transported home in a car in 30 037.95,127, 129, 173, 244, 261 Therefore, periods260, 264, 268; however, each safety seat regarding the need standard practice for fasting before of these reports has, for the most to carefully observe the child’s elective sedation generally follows part, clearly balanced the urgency head position to avoid airway the same guidelines as for elective of the procedure with the need obstruction. Transportation in a general anesthesia; this requirement for and depth of sedation.268, 269 car safety seat poses a particular is particularly important for solids, Although emergency medicine risk for infants who have received because aspiration of clear gastric studies and practice guidelines medications known to have a long contents causes less pulmonary generally support a less restrictive half-life, such as chloral hydrate, injury than aspiration of particulate approach to fasting for brief urgent/ intramuscular pentobarbital, or gastric contents.262, 263 emergent procedures, such as care of phenothiazine because deaths wounds, joint dislocation, chest tube after procedural sedation have For emergency procedures in placement, etc, in healthy children, been reported.62, 63, 238, 242, 256, 257 children undergoing general further research in many thousands Consideration for a longer period anesthesia, the reported incidence of patients would be desirable to of observation shall be given if of pulmonary aspiration of gastric better define the relationships the responsible person’s ability contents from 1 institution is between various fasting intervals and to observe the child is limited ∼1 in 373 compared with ∼1 in sedation complications.262–270 (eg, only 1 adult who also has 4544 for elective anesthetics.262 to drive). Another indication for Because there are few published Before Elective Sedation prolonged observation would be studies with adequate statistical Children undergoing sedation for a child with an anatomic airway power to provide guidance to the elective procedures generally should problem, an underlying medical practitioner regarding the safety follow the same fasting guidelines condition such as significant or risk of pulmonary aspiration of as those for general anesthesia obstructive sleep apnea (OSA), or gastric contents during procedural (Table 1).271 It is permissible for a former preterm infant younger sedation, 95, 127, 129, 173, 244, 259–261, 264–268, routine necessary medications (eg, than 60 weeks’ postconceptional it is unknown whether the risk of antiseizure medications) to be taken age. A 24-hour telephone number aspiration is reduced when airway with a sip of clear liquid or water on for the practitioner or his or her manipulation is not performed/ the day of the procedure. associates shall be provided to anticipated (eg, moderate sedation). all patients and their families. However, if a deeply sedated child For the Emergency Patient Instructions shall include requires intervention for airway The practitioner must always limitations of activities and obstruction, apnea, or laryngospasm, balance the possible risks of sedating appropriate dietary precautions. there is concern that these rescue nonfasted patients with the benefits maneuvers could increase the risk of and necessity for completing the Dietary Precautions of pulmonary aspiration of gastric procedure. In particular, patients contents. For children requiring with a history of recent oral intake Agents used for sedation have the urgent/emergent sedation who do or with other known risk factors, potential to impair protective airway not meet elective fasting guidelines, such as trauma, decreased level of reflexes, particularly during deep the risks of sedation and possible consciousness, extreme obesity (BMI sedation. Although a rare occurrence, aspiration are as-yet unknown ≥95% for age and sex), pregnancy, pulmonary aspiration may occur if and must be balanced against the or bowel motility dysfunction, the child regurgitates and cannot benefits of performing the procedure require careful evaluation before the protect his or her airway.95, 127, 258 promptly. For example, a prudent administration of sedatives. When Therefore, the practitioner should practitioner would be unlikely proper fasting has not been ensured,

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e6 FROM THE AMERICAN ACADEMY OF PEDIATRICS the increased risks of sedation must TABLE 1 Appropriate Intake of Food and Liquids Before Elective Sedation be carefully weighed against its Ingested Material Minimum Fasting Period, h benefits, and the lightest effective Clear liquids: water, fruit juices without pulp, carbonated beverages, 2 sedation should be used. In this clear tea, black coffee circumstance, additional techniques Human milk 4 for achieving analgesia and patient Infant formula 6 cooperation, such as distraction, Nonhuman milk: because nonhuman milk is similar to solids in gastric 6 emptying time, the amount ingested must be considered when guided imagery, video games, topical determining an appropriate fasting period. and local anesthetics, hematoma block Light meal: a light meal typically consists of toast and clear liquids. 6 or nerve blocks, and other techniques Meals that include fried or fatty foods or meat may prolong gastric advised by child life specialists, are emptying time. Both the amount and type of foods ingested must be particularly helpful and should be considered when determining an appropriate fasting period. considered.29, 49, 182–201, 274, 275 Source: American Society of Anesthesiologists. Practice guidelines for preoperative fasting and the use of pharmacologic agents to reduce the risk of pulmonary aspiration: application to healthy patients undergoing elective procedures. An The use of agents with less risk updated report by the American Society of Anesthesiologists Committee on Standards and Practice Parameters. Available of depressing protective airway at: https://www. asahq. org/ For- Members/ Practice- Management/ Practice- Parameters. aspx. For emergent sedation, the practitioner must balance the depth of sedation versus the risk of possible aspiration; see also Mace et al272 and Green et al.273 reflexes, such as ketamine, or moderate sedation, which would also but also to determine whether the P450 system, resulting in prolonged maintain protective reflexes, may patient has specific risk factors that sedation with midazolam as well as 276 be preferred. Some emergency may warrant additional consultation other medications competing for patients requiring deep sedation before sedation. This evaluation the same enzyme systems.300–304 (eg, a trauma patient who just also facilitates the identification Medications used to treat HIV ate a full meal or a child with a of patients who will require more infection, some anticonvulsants, bowel obstruction) may need to be advanced airway or cardiovascular immunosuppressive drugs, and intubated to protect their airway management skills or alterations in some psychotropic medications before they can be sedated. the doses or types of medications (often used to treat children with Use of Immobilization Devices used for procedural sedation. autism spectrum disorder) may also produce clinically important drug- (Protective Stabilization) An important concern for the drug interactions.305–314 Therefore, practitioner is the widespread Immobilization devices, such a careful drug history is a vital part use of medications that may as papoose boards, must be of the safe sedation of children. The interfere with drug absorption or applied in such a way as to avoid practitioner should consult various metabolism and therefore enhance airway obstruction or chest sources (a pharmacist, textbooks, 277–281 or shorten the effect time of sedating restriction. The child’s head online services, or handheld medications. Herbal medicines position and respiratory excursions databases) for specific information (eg, St John’s wort, ginkgo, ginger, should be checked frequently on drug interactions.315–319 The ginseng, garlic) may alter drug to ensure airway patency. If an US Food and Drug Administration pharmacokinetics through inhibition immobilization device is used, a issued a warning in February 2013 of the cytochrome P450 system, hand or foot should be kept exposed, regarding the use of codeine for resulting in prolonged drug effect and the child should never be left postoperative pain management in and altered (increased or decreased) unattended. If sedating medications children undergoing tonsillectomy, blood drug concentrations are administered in conjunction with particularly those with OSA. The (midazolam, cyclosporine, an immobilization device, monitoring safety issue is that some children tacrolimus).283–292 Kava may must be used at a level consistent have duplicated cytochromes increase the effects of sedatives with the level of sedation achieved. that allow greater than expected by potentiating γ-aminobutyric conversion of the prodrug codeine to Documentation at the Time of acid inhibitory neurotransmission morphine, thus resulting in potential Sedation and may increase acetaminophen- overdose; codeine should be avoided 1. Health evaluation: Before sedation, induced liver toxicity.293–295 Valerian for postprocedure analgesia.320–324 a health evaluation shall be performed may itself produce sedation that by an appropriately licensed apparently is mediated through the The health evaluation should include γ practitioner and reviewed by the modulation of -aminobutyric acid the following: sedation team at the time of treatment neurotransmission and receptor for possible interval changes.282 The function.291,296–299 Drugs such as • age and weight (in kg) and purpose of this evaluation is not erythromycin, cimetidine, and others gestational age at birth (preterm only to document baseline status may also inhibit the cytochrome infants may have associated

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e7 sequelae such as apnea of analgesic at opioid levels one-third 2. Prescriptions. When prescriptions prematurity); and to one-half those of a child without are used for sedation, a copy of the OSA325–328, 339, 340; lower titrated prescription or a note describing the • health history, including (1) food doses of opioids should be used content of the prescription should and medication allergies and in this population. Such a detailed be in the patient’s chart along with a previous allergic or adverse drug history will help to determine which description of the instructions that reactions; (2) medication/drug patients may benefit from a higher were given to the responsible person. history, including dosage, time, level of care by an appropriately Prescription medications intended route, and site of administration skilled health care provider, such to accomplish procedural sedation for prescription, over-the-counter, as an anesthesiologist. The health must not be administered without herbal, or illicit drugs; (3) relevant evaluation should also include: the safety net of direct supervision diseases, physical abnormalities by trained medical/dental (including genetic syndromes), • vital signs, including heart rate, personnel. The administration of neurologic impairments that blood pressure, respiratory rate, sedating medications at home poses might increase the potential for room air oxygen saturation, an unacceptable risk, particularly for airway obstruction, obesity, a and temperature (for some infants and preschool-aged children history of snoring or OSA, 325–328 or children who are very upset or traveling in car safety seats because cervical spine instability in Down noncooperative, this may not deaths as a result of this practice syndrome, Marfan syndrome, be possible and a note should have been reported.63, 257 skeletal dysplasia, and other be written to document this conditions; (4) pregnancy status circumstance); (as many as 1% of menarchal • Documentation During Treatment females presenting for general physical examination, including anesthesia at children’s hospitals a focused evaluation of the The patient’s chart shall contain are pregnant)329–331 because of con- airway (tonsillar hypertrophy, a time-based record that includes cerns for the potential adverse effects abnormal anatomy [eg, mandibular the name, route, site, time, dosage/ of most sedating and anesthetic hypoplasia], high Mallampati score kilogram, and patient effect of drugs on the fetus329, 332–338; [ie, ability to visualize only the administered drugs. Before sedation, (5) history of prematurity (may hard palate or tip of the uvula]) a “time out” should be performed be associated with subglottic to determine whether there to confirm the patient’s name, stenosis or propensity to apnea is an increased risk of airway procedure to be performed, and 74, 341–344 59 after sedation); (6) history of any obstruction ; laterality and site of the procedure. During administration, the inspired seizure disorder; (7) summary of • physical status evaluation (ASA concentrations of oxygen and previous relevant hospitalizations; classification [see Appendix 2]); inhalation sedation agents and the (8) history of sedation or general and anesthesia and any complications duration of their administration • or unexpected responses; and name, address, and telephone shall be documented. Before drug (9) relevant family history, number of the child’s home or administration, special attention particularly related to anesthesia parent’s, or caregiver’s cell phone; must be paid to the calculation (eg, muscular dystrophy, additional information such as the of dosage (ie, mg/kg); for obese malignant hyperthermia, patient’s personal care provider or patients, most drug doses should pseudocholinesterase deficiency). medical home is also encouraged. likely be adjusted lower to ideal body weight rather than actual weight.345 The review of systems should For hospitalized patients, the When a programmable pump is focus on abnormalities of cardiac, current hospital record may suffice used for the infusion of sedating pulmonary, renal, or hepatic for adequate documentation of medications, the dose/kilogram per function that might alter the presedation health; however, a note minute or hour and the child’s weight child’s expected responses to shall be written documenting that the in kilograms should be double- sedating/analgesic medications. chart was reviewed, positive findings checked and confirmed by a separate A specific query regarding signs were noted, and a management plan individual. The patient’s chart shall and symptoms of sleep-disordered was formulated. If the clinical or contain documentation at the time of breathing and OSA may be helpful. emergency condition of the patient treatment that the patient’s level of Children with severe OSA who have precludes acquiring complete consciousness and responsiveness, experienced repeated episodes information before sedation, this heart rate, blood pressure, of desaturation will likely have health evaluation should be obtained respiratory rate, expired carbon altered mu receptors and be as soon as feasible. dioxide values, and oxygen saturation

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e8 FROM THE AMERICAN ACADEMY OF PEDIATRICS were monitored. Standard vital Therefore, each facility should emergency, including antagonists signs should be further documented maintain records that track all as indicated at appropriate intervals during adverse events and significant M = Monitors: functioning pulse recovery until the patient attains interventions, such as desaturation; oximeter with size-appropriate predetermined discharge criteria apnea; laryngospasm; need for oximeter probes, 361, 362 end-tidal (Appendix 1). A variety of sedation airway interventions, including the carbon dioxide monitor, and other scoring systems are available that need for placement of supraglottic monitors as appropriate for the 212, 238, 346–348 may aid this process. devices such as an oral airway, procedure (eg, noninvasive blood Adverse events and their treatment nasal trumpet, or LMA; positive- pressure, ECG, stethoscope) shall be documented. pressure ventilation; prolonged E sedation; unanticipated use of = special Equipment or drugs for a Documentation After Treatment reversal agents; unplanned or particular case (eg, defibrillator) A dedicated and properly equipped prolonged hospital admission; recovery area is recommended (see sedation failures; inability to Appendices 3 and 4). The time and complete the procedure; and SPECIFIC GUIDELINES FOR INTENDED condition of the child at discharge unsatisfactory sedation, analgesia, LEVEL OF SEDATION or anxiolysis.360 Such events from the treatment area or facility Minimal Sedation shall be documented, which should can then be examined for the include documentation that the assessment of risk reduction and Minimal sedation (old terminology, child’s level of consciousness and improvement in patient/family “anxiolysis”) is a drug-induced state oxygen saturation in room air have satisfaction. during which patients respond returned to a state that is safe for normally to verbal commands. discharge by recognized criteria Although cognitive function and (see Appendix 1). Patients receiving PREPARATION FOR SEDATION coordination may be impaired, PROCEDURES supplemental oxygen before the ventilatory and cardiovascular procedure should have a similar Part of the safety net of sedation is functions are unaffected. Children oxygen need after the procedure. using a systematic approach so as who have received minimal sedation Because some sedation medications to not overlook having an important generally will not require more are known to have a long half-life drug, piece of equipment, or monitor than observation and intermittent and may delay a patient’s complete immediately available at the time of assessment of their level of return to baseline or pose the a developing emergency. To avoid sedation. Some children will become risk of re-sedation62, 104, 256, 349, 350 this problem, it is helpful to use an moderately sedated despite the and because some patients will acronym that allows the same setup intended level of minimal sedation; have complex multiorgan medical and checklist for every procedure. should this occur, then the guidelines 85, 363 conditions, a longer period of A commonly used acronym useful for moderate sedation apply. observation in a less intense in planning and preparation for Moderate Sedation observation area (eg, a step-down a procedure is SOAPME, which observation area) before discharge represents the following: Moderate sedation (old terminology, from medical/dental supervision “conscious sedation” or “sedation/ S may be indicated.239 Several scales to = Size-appropriate suction catheters analgesia”) is a drug-induced evaluate recovery have been devised and a functioning suction apparatus depression of consciousness during and validated.212, 346–348, 351, 352 A (eg, Yankauer-type suction) which patients respond purposefully simple evaluation tool may be the O = an adequate Oxygen supply and to verbal commands or after light ability of the infant or child to remain functioning flow meters or other tactile stimulation. No interventions awake for at least 20 minutes when devices to allow its delivery are required to maintain a patent 238 airway, and spontaneous ventilation placed in a quiet environment. A = size-appropriate Airway equipment is adequate. Cardiovascular function is (eg, bag-valve-mask or equivalent usually maintained. The caveat that loss device [functioning]), nasopharyngeal of consciousness should be unlikely is CONTINUOUS QUALITY IMPROVEMENT and oropharyngeal airways, LMA, a particularly important aspect of the The essence of medical error laryngoscope blades (checked and definition of moderate sedation; drugs reduction is a careful examination functioning), endotracheal tubes, and techniques used should carry a of index events and root-cause stylets, face mask margin of safety wide enough to render analysis of how the event could P = Pharmacy: all the basic drugs unintended loss of consciousness be avoided in the future.353–359 needed to support life during an unlikely. Because the patient who

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e9 receives moderate sedation may in periodic reviews, simulation of expired carbon dioxide values should progress into a state of deep sedation rare emergencies, and practice drills be recorded, at minimum, every 10 and obtundation, the practitioner of the facility’s emergency protocol minutes in a time-based record. Note should be prepared to increase the level to ensure proper function of the that the exact value of expired carbon of vigilance corresponding to what is equipment and coordination of staff dioxide is less important than simple necessary for deep sedation.85 roles in such emergencies.133,365–367 assessment of continuous respiratory It is recommended that at least 1 gas exchange. In some situations Personnel practitioner be skilled in obtaining in which there is excessive patient THE PRACTITIONER. The practitioner vascular access in children. agitation or lack of cooperation or responsible for the treatment of the during certain procedures such as Monitoring and Documentation patient and/or the administration bronchoscopy, dentistry, or repair of drugs for sedation must be BASELINE. Before the administration of facial lacerations capnography competent to use such techniques, of sedative medications, a baseline may not be feasible, and this to provide the level of monitoring determination of vital signs shall be situation should be documented. For described in these guidelines, and documented. For some children who uncooperative children, it is often to manage complications of these are very upset or uncooperative, helpful to defer the initiation of techniques (ie, to be able to rescue this may not be possible, and a note capnography until the child becomes the patient). Because the level of should be written to document this sedated. Similarly, the stimulation intended sedation may be exceeded, circumstance. of blood pressure cuff inflation may the practitioner must be sufficiently cause arousal or agitation; in such skilled to rescue a child with apnea, DURING THE PROCEDURE The physician/ cases, blood pressure monitoring laryngospasm, and/or airway dentist or his or her designee may be counterproductive and may obstruction, including the ability to shall document the name, route, be documented at less frequent open the airway, suction secretions, site, time of administration, and intervals (eg, 10–15 minutes, provide CPAP, and perform dosage of all drugs administered. assuming the patient remains stable, successful bag-valve-mask ventilation If sedation is being directed by a well oxygenated, and well perfused). should the child progress to a level physician who is not personally Immobilization devices (protective of deep sedation. Training in, and administering the medications, stabilization) should be checked to maintenance of, advanced pediatric then recommended practice is for prevent airway obstruction or chest airway skills is required (eg, the qualified health care provider restriction. If a restraint device is pediatric advanced life support administering the medication to used, a hand or foot should be kept [PALS]); regular skills reinforcement confirm the dose verbally before exposed. The child’s head position with simulation is strongly administration. There shall be should be continuously assessed to encouraged.79, 80, 128, 130, 217–220, 364 continuous monitoring of oxygen ensure airway patency. saturation and heart rate; when SUPPORT PERSONNEL. The use of moderate bidirectional verbal communication AFTER THE PROCEDURE. The child who has sedation shall include the provision of a between the provider and patient received moderate sedation must person, in addition to the practitioner, is appropriate and possible (ie, be observed in a suitably equipped whose responsibility is to monitor patient is developmentally able recovery area, which must have appropriate physiologic parameters and purposefully communicates), a functioning suction apparatus and to assist in any supportive or monitoring of ventilation by as well as the capacity to deliver resuscitation measures, if required. (1) capnography (preferred) >90% oxygen and positive-pressure This individual may also be responsible or (2) amplified, audible ventilation (bag-valve mask) with for assisting with interruptible pretracheal stethoscope (eg, an adequate oxygen capacity as patient-related tasks of short duration, Bluetooth technology)368–371 or well as age- and size-appropriate such as holding an instrument or precordial stethoscope is strongly rescue equipment and devices. troubleshooting equipment.60 This recommended. If bidirectional The patient’s vital signs should be individual should be trained in and verbal communication is not recorded at specific intervals (eg, capable of providing advanced airway appropriate or not possible, every 10–15 minutes). If the patient skills (eg, PALS). The support person monitoring of ventilation by is not fully alert, oxygen saturation shall have specific assignments in the capnography (preferred), amplified, and heart rate monitoring shall be event of an emergency and current audible pretracheal stethoscope, or used continuously until appropriate knowledge of the emergency cart precordial stethoscope is required. discharge criteria are met (see inventory. The practitioner and all Heart rate, respiratory rate, blood Appendix 1). Because sedation ancillary personnel should participate pressure, oxygen saturation, and medications with a long half-life

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e10 FROM THE AMERICAN ACADEMY OF PEDIATRICS may delay the patient’s complete “General anesthesia” is a drug- have a person skilled in establishing return to baseline or pose the induced loss of consciousness during vascular access in pediatric patients risk of re-sedation, some patients which patients are not arousable, immediately available. might benefit from a longer period even by painful stimulation. The of less intense observation (eg, a ability to independently maintain Monitoring step-down observation area where ventilatory function is often multiple patients can be observed impaired. Patients often require A competent individual shall simultaneously) before discharge assistance in maintaining a patent observe the patient continuously. from medical/dental supervision airway, and positive-pressure Monitoring shall include all (see section entitled “Documentation ventilation may be required because parameters described for moderate Before Sedation” above).62, 256, 349, 350 of depressed spontaneous ventilation sedation. Vital signs, including A simple evaluation tool may be the or drug-induced depression heart rate, respiratory rate, blood ability of the infant or child to remain of neuromuscular function. pressure, oxygen saturation, and awake for at least 20 minutes when Cardiovascular function may be expired carbon dioxide, must be placed in a quiet environment.238 impaired. documented at least every 5 minutes Patients who have received reversal in a time-based record. Capnography agents, such as flumazenil or should be used for almost all deeply naloxone, will require a longer period Personnel sedated children because of the increased risk of airway/ventilation of observation, because the duration During deep sedation, there of the drugs administered may compromise. Capnography may must be 1 person whose only not be feasible if the patient is exceed the duration of the antagonist, responsibility is to constantly resulting in re-sedation. agitated or uncooperative during observe the patient’s vital signs, the initial phases of sedation or airway patency, and adequacy of during certain procedures, such as Deep Sedation/General Anesthesia ventilation and to either administer bronchoscopy or repair of facial drugs or direct their administration. “Deep sedation” (“deep sedation/ lacerations, and this circumstance This individual must, at a minimum, should be documented. For analgesia”) is a drug-induced be trained in PALS and capable depression of consciousness during uncooperative children, the of assisting with any emergency capnography monitor may be which patients cannot be easily event. At least 1 individual must aroused but respond purposefully placed once the child becomes be present who is trained in and sedated. Note that if supplemental after repeated verbal or painful capable of providing advanced stimulation (eg, purposefully pushing oxygen is administered, the pediatric life support and who is capnograph may underestimate away the noxious stimuli). Reflex skilled to rescue a child with apnea, withdrawal from a painful stimulus the true expired carbon dioxide laryngospasm, and/or airway value; of more importance than is not considered a purposeful obstruction. Required skills include response and is more consistent with the numeric reading of exhaled the ability to open the airway, carbon dioxide is the assurance a state of general anesthesia. The suction secretions, provide CPAP, ability to independently maintain of continuous respiratory gas insert supraglottic devices (oral exchange (ie, continuous waveform). ventilatory function may be impaired. airway, nasal trumpet, LMA), and Patients may require assistance in Capnography is particularly useful perform successful bag-valve-mask for patients who are difficult to maintaining a patent airway, and ventilation, tracheal intubation, and spontaneous ventilation may be observe (eg, during MRI or in a cardiopulmonary resuscitation. 64,67, 72, 90, 96, 110, inadequate. Cardiovascular function darkened room). 159–162,164–166, 167–170, 372–375 is usually maintained. A state of deep Equipment sedation may be accompanied by The physician/dentist or his or her partial or complete loss of protective In addition to the equipment needed designee shall document the name, airway reflexes. Patients may pass for moderate sedation, an ECG route, site, time of administration, from a state of deep sedation to the monitor and a defibrillator for use in and dosage of all drugs administered. state of general anesthesia. In some pediatric patients should be readily If sedation is being directed by a situations, such as during MRI, one is available. physician who is not personally not usually able to assess responses administering the medications, then Vascular Access to stimulation, because this would recommended practice is for the defeat the purpose of sedation, and Patients receiving deep sedation nurse administering the medication one should assume that such patients should have an intravenous line to confirm the dose verbally before are deeply sedated. placed at the start of the procedure or administration. The inspired

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e11 concentrations of inhalation sedation TABLE 2 Comparison of Moderate and Deep Sedation Equipment and Personnel Requirements agents and oxygen and the duration of Moderate Sedation Deep Sedation administration shall be documented. Personnel An observer who will monitor An independent observer Postsedation Care the patient but who may whose only responsibility is also assist with interruptible to continuously monitor the The facility and procedures tasks; should be trained in patient; trained in PALS followed for postsedation care shall PALS Responsible practitioner Skilled to rescue a child with Skilled to rescue a child with conform to those described under apnea, laryngospasm, and/or apnea, laryngospasm, and/or “moderate sedation.” The initial airway obstruction including airway obstruction, including recording of vital signs should the ability to open the airway, the ability to open the airway, be documented at least every 5 suction secretions, provide suction secretions, provide minutes. Once the child begins to CPAP, and perform successful CPAP, perform successful bag-valve-mask ventilation; bag-valve-mask ventilation, awaken, the recording intervals may recommended that at least 1 tracheal intubation, and be increased to 10 to 15 minutes. practitioner should be skilled cardiopulmonary resuscitation; Table 2 summarizes the equipment, in obtaining vascular access training in PALS is required; at personnel, and monitoring in children; trained in PALS least 1 practitioner skilled in requirements for moderate and obtaining vascular access in children immediately available deep sedation. Monitoring Pulse oximetry Pulse oximetry ECG recommended ECG required Heart rate Heart rate Special Considerations Blood pressure Blood pressure Neonates and Former Preterm Infants Respiration Respiration Capnography recommended Capnography required Neonates and former preterm Other equipment Suction equipment, adequate Suction equipment, adequate infants require specific management, oxygen source/supply oxygen source/supply, because immaturity of hepatic and deﬁ brillator required renal function may alter the ability Documentation Name, route, site, time of Name, route, site, time of administration, and dosage of administration, and dosage to metabolize and excrete sedating all drugs administered of all drugs administered; 376 medications, resulting in prolonged Continuous oxygen saturation, continuous oxygen saturation, sedation and the need for extended heart rate, and ventilation heart rate, and ventilation postsedation monitoring. Former (capnography recommended); (capnography required); preterm infants have an increased parameters recorded every parameters recorded at least 10 minutes every 5 minutes risk of postanesthesia apnea,377 Emergency checklists Recommended Recommended but it is unclear whether a similar Rescue cart properly stocked Required Required risk is associated with sedation, with rescue drugs and because this possibility has not been age- and size-appropriate systematically investigated.378 equipment (see Appendices 3 and 4) Other concerns regarding the effects Dedicated recovery area with Recommended; initial recording Recommended; initial recording of anesthetic drugs and sedating rescue cart properly stocked of vital signs may be needed of vital signs may be needed for medications on the developing with rescue drugs and at least every 10 minutes until at least 5-minute intervals until age- and size-appropriate the child begins to awaken, the child begins to awaken, brain are beyond the scope of this equipment (see Appendices 3 then recording intervals may then recording intervals may be document. At this point, the research and 4) and dedicated recovery be increased increased to 10–15 minutes in this area is preliminary and personnel; adequate oxygen inconclusive at best, but it would supply seem prudent to avoid unnecessary Discharge criteria See Appendix 1 See Appendix 1 exposure to sedation if the procedure is unlikely to change medical/dental cause central nervous system administration. There may be management (eg, a sedated MRI excitation or depression. Particular enhanced sedative effects when purely for screening purposes in weight-based attention should be the highest recommended doses of preterm infants).379–382 paid to cumulative dosage in all local anesthetic drugs are used in children.118, 120, 125, 383–386 To ensure combination with other sedatives or Local Anesthetic Agents that the patient will not receive an opioids (see Tables 3 and 4 for limits excessive dose, the maximum and conversion tables of commonly All local anesthetic agents are cardiac allowable safe dosage (eg, mg/kg) used local anesthetics).118, 125, 387–400 depressants and may should be calculated before In general, when administering local

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e12 FROM THE AMERICAN ACADEMY OF PEDIATRICS TABLE 3 Commonly Used Local Anesthetic Agents for Nerve Block or Inﬁ ltration: Doses, Duration, and Calculations Local Anesthetic Maximum Dose With Epinephrine,a Maximum Dose Without Epinephrine, Duration of Action,b min mg/kg mg/kg Medical Dental Medical Dental Esters Procaine 10.0 6 7 6 60–90 Chloroprocaine 20.0 12 15 12 30–60 Tetracaine 1.5 1 1 1 180–600 Amides Lidocaine 7.0 4.4 4 4.4 90–200 Mepivacaine 7.0 4.4 5 4.4 120–240 Bupivacaine 3.0 1.3 2.5 1.3 180–600 Levobupivacainec 3.0 2 2 2 180–600 Ropivacaine 3.0 2 2 2 180–600 Articained — 7 — 7 60–230 Maximum recommended doses and durations of action are shown. Note that lower doses should be used in very vascular areas. a These are maximum doses of local anesthetics combined with epinephrine; lower doses are recommended when used without epinephrine. Doses of amides should be decreased by 30% in infants younger than 6 mo. When lidocaine is being administered intravascularly (eg, during intravenous regional anesthesia), the dose should be decreased to 3 to 5 mg/kg; long-acting local anesthetic agents should not be used for intravenous regional anesthesia. b Duration of action is dependent on concentration, total dose, and site of administration; use of epinephrine; and the patient’s age. c Levobupivacaine is not available in the United States. d Use in pediatric patients under 4 years of age is not recommended.

TABLE 4 Local Anesthetic Conversion Chart TABLE 5 Treatment of Local Anesthetic Toxicity Concentration, % mg/mL 1. Get help. Ventilate with 100% oxygen. Alert nearest facility with cardiopulmonary bypass capability. 2. Resuscitation: airway/ventilatory support, chest compressions, etc. Avoid vasopressin, calcium 4.0 40 channel blockers, β-blockers, or additional local anesthetic. Reduce epinephrine dosages. Prolonged 3.0 30 effort may be required. 2.5 25 3. Seizure management: benzodiazepines preferred (eg, intravenous midazolam 0.1–0.2 mg/kg); avoid 2.0 20 propofol if cardiovascular instability. 1.0 10 4. Administer 1.5 mL/kg 20% lipid emulsion over ∼1 minute to trap unbound amide local anesthetics. 0.5 5 Repeat bolus once or twice for persistent cardiovascular collapse. 0.25 2.5 5. Initiate 20% lipid infusion (0.25 mL/kg per minute) until circulation is restored; double the infusion 0.125 1.25 rate if blood pressure remains low. Continue infusion for at least 10 minutes after attaining circulatory stability. Recommended upper limit of ∼10 mL/kg. anesthetic drugs, the practitioner 6. A ﬂ uid bolus of 10–20 mL/kg balanced salt solution and an infusion of phenylephrine (0.1 μg/kg per should aspirate frequently to minute to start) may be needed to correct peripheral vasodilation. minimize the likelihood that Source: https://www. asra. com/ advisory- guidelines/ article/ 3/ checklist- for- treatment- of- local- anesthetic- systemic- toxicity. the needle is in a blood vessel; lower doses should be used when Pulse Oximetry presence or absence of respirations, injecting into vascular tissues.401 airway obstruction, or respiratory Newer pulse oximeters are less If high doses or injection of amide depression, particularly in patients susceptible to motion artifacts and local anesthetics (bupivacaine and sedated in less-accessible locations, may be more useful than older ropivacaine) into vascular tissues such as in MRI machines or darkened oximeters that do not contain is anticipated, then the immediate rooms.64, 66, 67, 72, 90, 96, 110, 159–162, 164–170, updated software.416–420 Oximeters availability of a 20% lipid emulsion 372–375, 421–427 In patients receiving that change tone with changes in for the treatment of local anesthetic supplemental oxygen, capnography hemoglobin saturation provide toxicity is recommended (Tables facilitates the recognition of apnea immediate aural warning to everyone 3 and 5).402–409 Topical local or airway obstruction several within hearing distance. The oximeter anesthetics are commonly used and minutes before the situation would probe must be properly positioned; encouraged, but the practitioner be detected just by pulse oximetry. clip-on devices are easy to displace, should avoid applying excessive In this situation, desaturation would which may produce artifactual data doses to mucosal surfaces where be delayed due to increased oxygen (under- or overestimation of oxygen systemic uptake and possible toxicity reserves; capnography would enable saturation).361,362 (seizures, methemoglobinemia) earlier intervention.161 One study in could result and to remain within the Capnography children sedated in the emergency manufacturer’s recommendations department found that the use of regarding allowable surface area Expired carbon dioxide monitoring capnography reduced the incidence application.410–415 is valuable to diagnose the simple of hypoventilation and desaturation

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e13 (7% to 1%).174 The use of expired with stage 2 sleep.431 Several experience with these techniques as carbon dioxide monitoring devices sedation studies have examined the they become incorporated into PALS is now required for almost all utility of this device and degree of courses. deeply sedated children (with rare correlation with standard sedation Another valuable emergency exceptions), particularly in situations scales.347, 363, 432–435 It appears that technique is intraosseous needle in which other means of assessing there is some correlation with BIS placement for vascular access. the adequacy of ventilation are values in moderate sedation, but Intraosseous needles are available limited. Several manufacturers have there is not a reliable ability to in several sizes; insertion can be produced nasal cannulae that allow distinguish between deep sedation life-saving when rapid intravenous simultaneous delivery of oxygen and moderate sedation or deep access is difficult. A relatively new and measurement of expired carbon sedation from general anesthesia.432 intraosseous device (EZ-IO Vidacare, dioxide values.421, 422, 427 Although Presently, it would appear that BIS now part of Teleflex, Research these devices can have a high degree monitoring might provide useful Triangle Park, NC) is similar to a of false-positive alarms, they are information only when used for hand-held battery-powered drill. also very accurate for the detection sedation with propofol363; in general, It allows rapid placement with of complete airway obstruction or it is still considered a research tool minimal chance of misplacement; it apnea.164, 168, 169 Taping the sampling and not recommended for routine also has a low-profile intravenous line under the nares under an oxygen use. adapter.445–450 Familiarity with the face mask or nasal hood will provide use of these emergency techniques similar information. The exact can be gained by keeping current measured value is less important Adjuncts to Airway Management and with resuscitation courses, such as than the simple answer to the Resuscitation PALS and advanced pediatric life question: Is the child exchanging air support. with each breath? The vast majority of sedation complications can be managed Processed EEG (Bispectral Index) with simple maneuvers, such as Patient Simulators Although not new to the anesthesia supplemental oxygen, opening the High-fidelity patient simulators are community, the processed EEG airway, suctioning, placement of an now available that allow physicians, (bispectral index [BIS]) monitor oral or nasopharyngeal airway, and dentists, and other health care is slowly finding its way into the bag-mask-valve ventilation. Rarely, providers to practice managing a sedation literature.428 Several studies tracheal intubation is required variety of programmed adverse have attempted to use BIS monitoring for more prolonged ventilatory events, such as apnea, bronchospasm, as a means of noninvasively support. In addition to standard and laryngospasm.133, 220, 450–452, The assessing the depth of sedation. This tracheal intubation techniques, use of such devices is encouraged to technology was designed to examine a number of supraglottic devices better train medical professionals and EEG signals and, through a variety are available for the management teams to respond more effectively of algorithms, correlate a number of patients with abnormal airway to rare events.128, 131, 451, 453–455 One with depth of unconsciousness: anatomy or airway obstruction. study that simulated the quality that is, the lower the number, the Examples include the LMA, the cuffed of cardiopulmonary resuscitation deeper the sedation. Unfortunately, oropharyngeal airway, and a variety compared standard management these algorithms are based on adult of kits to perform an emergency of ventricular fibrillation versus 436, 437 patients and have not been validated cricothyrotomy. rescue with the EZ-IO for the rapid in children of varying ages and The largest clinical experience in establishment of intravenous varying brain development. Although pediatrics is with the LMA, which is access and placement of an LMA the readings correspond quite well available in multiple sizes, including for establishing a patent airway with the depth of propofol sedation, those for late preterm and term in adults; the use of these devices the numbers may paradoxically go up neonates. The use of the LMA is now resulted in more rapid establishment rather than down with sevoflurane an essential addition to advanced of vascular access and securing of and ketamine because of central airway training courses, and the airway.456 excitation despite a state of general familiarity with insertion techniques anesthesia or deep sedation.429, 430 can be life-saving.438–442 The LMA Monitoring During MRI Opioids and benzodiazepines have can also serve as a bridge to secure The powerful magnetic field and minimal and variable effects on the airway management in children with the generation of radiofrequency BIS. Dexmedetomidine has minimal anatomic airway abnormalities.443, 444 emissions necessitate the use effect with EEG patterns, consistent Practitioners are encouraged to gain of special equipment to provide

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e14 FROM THE AMERICAN ACADEMY OF PEDIATRICS continuous patient monitoring a calibrated and functional oxygen In this situation, the practitioner is throughout the MRI scanning analyzer. All nitrous oxide-to- advised to institute the guidelines procedure.457–459 MRI-compatible oxygen inhalation devices should for moderate or deep sedation, pulse oximeters and capnographs be calibrated in accordance as indicated by the patient’s capable of continuous function with appropriate state and local response.496 during scanning should be used in requirements. Consideration should any sedated or restrained pediatric be given to the National Institute patient. Thermal injuries can result of Occupational Safety and Health ACKNOWLEDMENTS if appropriate precautions are not Standards for the scavenging of The lead authors thank Dr Corrie taken; the practitioner is cautioned to waste gases.464 Newly constructed Chumpitazi and Dr Mary Hegenbarth avoid coiling of all wires (oximeter, or reconstructed treatment for their contributions to this ECG) and to place the oximeter facilities, especially those with document. probe as far from the magnetic piped-in nitrous oxide and oxygen, coil as possible to diminish the must have appropriate state or LEAD AUTHORS possibility of injury. ECG monitoring local inspections to certify proper Charles J. Coté, MD, FAAP during MRI has been associated function of inhalation sedation/ Stephen Wilson, DMD, MA, PhD with thermal injury; special MRI- analgesia systems before any compatible ECG pads are essential delivery of patient care. AMERICAN ACADEMY OF PEDIATRICS to allow safe monitoring.460–463 If sedation is achieved by using an Nitrous oxide in oxygen, with AMERICAN ACADEMY OF PEDIATRIC infusion pump, then either an MRI- varying concentrations, has been DENTISTRY compatible pump is required or the successfully used for many years pump must be situated outside of the to provide analgesia for a variety STAFF room with long infusion tubing so of painful procedures in Jennifer Riefe, MEd as to maintain infusion accuracy. All children.14, 36, 49, 98, 465–493 The use of Raymond J. Koteras, MHA equipment must be MRI compatible, nitrous oxide for minimal sedation including laryngoscope blades and is defined as the administration ≤ handles, oxygen tanks, and any of nitrous oxide of 50% with the ABBREVIATIONS ancillary equipment. All individuals, balance as oxygen, without any other including parents, must be screened sedative, opioid, or other depressant AAP: American Academy of for ferromagnetic materials, phones, drug before or concurrent with Pediatrics pagers, pens, credit cards, watches, the nitrous oxide to an otherwise AAPD: American Academy of surgical implants, pacemakers, etc, healthy patient in ASA class I or Pediatric Dentistry before entry into the MRI suite. II. The patient is able to maintain ASA: American Society of Anes- verbal communication throughout thesiologists BIS: bispectral index Nitrous Oxide the procedure. It should be noted CPAP: continuous positive airway Inhalation sedation/analgesia that although local anesthetics have pressure equipment that delivers nitrous sedative properties, for purposes of ECG: electrocardiography oxide must have the capacity of this guideline they are not considered EEG: electroencephalogram/elec- delivering 100% and never less sedatives in this circumstance. If troencephalography than 25% oxygen concentration nitrous oxide in oxygen is combined EMS: emergency medical services at a flow rate appropriate to the with other sedating medications, LMA: laryngeal mask airway size of the patient. Equipment such as chloral hydrate, midazolam, MRI: magnetic resonance imaging that delivers variable ratios of or an opioid, or if nitrous oxide is OSA: obstructive sleep apnea nitrous oxide >50% to oxygen used in concentrations >50%, the PALS: pediatric advanced life that covers the mouth and nose likelihood for moderate or deep support must be used in conjunction with sedation increases.107, 197, 492, 494, 495

FINANCIAL DISCLOSURE: The authors have indicated they do not have a ﬁ nancial relationship relevant to this article to disclose. FUNDING: No external funding. POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conﬂ icts of interest to disclose.

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e15 REFERENCES of chloral hydrate and midazolam 23. Bhatt-Mehta V, Rosen DA. Sedation sedation in children undergoing in children: current concepts. 1. Milnes AR. Intravenous procedural echocardiography. Clin Pediatr (Phila). Pharmacotherapy. 1998;18(4):790–807 sedation: an alternative to general 2001;40(7):381–387 anesthesia in the treatment of early 24. Morton NS, Oomen GJ. Development of childhood caries. J Can Dent Assoc. 13. Hain RD, Campbell C. Invasive a selection and monitoring protocol 2003;69:298–302 procedures carried out in conscious for safe sedation of children. Paediatr 2. Law AK, Ng DK, Chan KK. Use of children: contrast between North Anaesth. 1998;8(1):65–68 American and European paediatric intramuscular ketamine for endoscopy 25. Murphy MS. Sedation for invasive oncology centres. Arch Dis Child. sedation in children. Pediatr Int. procedures in paediatrics. Arch Dis 2001;85(1):12–15 2003;45(2):180–185 Child. 1997;77(4):281–284 14. Kennedy RM, Luhmann JD. 3. Flood RG, Krauss B. Procedural 26. Webb MD, Moore PA. Sedation for Pharmacological management of sedation and analgesia for children pediatric dental patients. Dent Clin pain and anxiety during emergency in the emergency department. Emerg North Am. 2002;46(4):803–814, xi Med Clin North Am. 2003;21(1):121–139 procedures in children. Paediatr Drugs. 2001;3(5):337–354 27. Malviya S, Voepel-Lewis T, Tait AR, 4. Jaggar SI, Haxby E. Sedation, Merkel S. Sedation/analgesia for 15. Kanagasundaram SA, Lane LJ, anaesthesia and monitoring for diagnostic and therapeutic procedures Cavalletto BP, Keneally JP, Cooper MG. bronchoscopy. Paediatr Respir Rev. in children. J Perianesth Nurs. Effi cacy and safety of nitrous oxide 2002;3(4):321–327 2000;15(6):415–422 in alleviating pain and anxiety during 5. de Blic J, Marchac V, Scheinmann P. painful procedures. Arch Dis Child. 28. Zempsky WT, Schechter NL. Offi ce- Complications of fl exible bronchoscopy 2001;84(6):492–495 based pain managemen: the 15-minute in children: prospective study of consultation. Pediatr Clin North Am. 16. Younge PA, Kendall JM. Sedation for 1,328 procedures. Eur Respir J. 2000;47(3):601–615 2002;20(5):1271–1276 children requiring wound repair: a randomised controlled double 29. Kennedy RM, Luhmann JD. The 6. Mason KP, Michna E, DiNardo JA, blind comparison of oral midazolam “ouchless emergency department”: et al. Evolution of a protocol for and oral ketamine. Emerg Med J. getting closer: advances in decreasing ketamine-induced sedation as an 2001;18(1):30–33 distress during painful procedures in alternative to general anesthesia for the emergency department. Pediatr interventional radiologic procedures 17. Ljungman G, Gordh T, Sörensen S, Clin North Am. 1999;46(6):1215–1247, in pediatric patients. Radiology. Kreuger A. Lumbar puncture in vii–viii 2002;225(2):457–465 pediatric oncology: conscious sedation 30. Rodriguez E, Jordan R. Contemporary 7. Houpt M. Project USAP 2000—use of vs. general anesthesia. Med Pediatr trends in pediatric sedation and sedative agents by pediatric dentists: a Oncol. 2001;36(3):372–379 analgesia. Emerg Med Clin North Am. 15-year follow-up survey. Pediatr Dent. 18. Poe SS, Nolan MT, Dang D, et al. 2002;20(1):199–222 2002;24(4):289–294 Ensuring safety of patients 8. Vinson DR, Bradbury DR. Etomidate receiving sedation for procedures: 31. Ruess L, O’Connor SC, Mikita CP, for procedural sedation in evaluation of clinical practice Creamer KM. Sedation for pediatric emergency medicine. Ann Emerg Med. guidelines. Jt Comm J Qual Improv. diagnostic imaging: use of pediatric 2002;39(6):592–598 2001;27(1):28–41 and nursing resources as an alternative to a radiology department 19. D’Agostino J, Terndrup TE. Chloral 9. Everitt IJ, Barnett P. Comparison of sedation team. Pediatr Radiol. hydrate versus midazolam for sedation two benzodiazepines used for sedation 2002;32(7):505–510 of children undergoing suturing of children for neuroimaging: a of a laceration in an emergency randomized clinical trial. Pediatr 32. Weiss S. Sedation of pediatric patients department. Pediatr Emerg Care. Emerg Care. 2000;16(1):1–4 for nuclear medicine procedures. Semin Nucl Med. 1993;23(3):190–198 2002;18(2):72–74 20. Green SM, Kuppermann N, Rothrock 10. Karian VE, Burrows PE, Zurakowski D, SG, Hummel CB, Ho M. Predictors of 33. Wilson S. Pharmacologic behavior Connor L, Poznauskis L, Mason KP. The adverse events with intramuscular management for pediatric dental development of a pediatric radiology ketamine sedation in children. Ann treatment. Pediatr Clin North Am. sedation program. Pediatr Radiol. Emerg Med. 2000;35(1):35–42 2000;47(5):1159–1175 2002;32(5):348–353 21. Hopkins KL, Davis PC, Sanders CL, 34. McCarty EC, Mencio GA, Green NE. 11. Kaplan RF, Yang CI. Sedation and Churchill LH. Sedation for pediatric Anesthesia and analgesia for the analgesia in pediatric patients for imaging studies. Neuroimaging Clin N ambulatory management of fractures procedures outside the operating Am. 1999;9(1):1–10 in children. J Am Acad Orthop Surg. room. Anesthesiol Clin North America. 22. Bauman LA, Kish I, Baumann RC, 1999;7(2):81–91 2002;20(1):181–194, vii Politis GD. Pediatric sedation 35. Egelhoff JC, Ball WS Jr, Koch BL, Parks 12. Wheeler DS, Jensen RA, Poss WB. A with analgesia. Am J Emerg Med. TD. Safety and effi cacy of sedation in randomized, blinded comparison 1999;17(1):1–3 children using a structured sedation

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e16 FROM THE AMERICAN ACADEMY OF PEDIATRICS program. AJR Am J Roentgenol. 46. Alexander M. Managing patient stress of pediatric patients during and 1997;168(5):1259–1262 in pediatric radiology. Radiol Technol. after sedation for diagnostic and 2012;83(6):549–560 therapeutic procedures: addendum. 36. Heinrich M, Menzel C, Hoffmann Pediatrics. 2002;110(4):836–838 F, Berger M, Schweinitz DV. Self- 47. Macias CG, Chumpitazi CE. Sedation administered procedural analgesia and anesthesia for CT: emerging issues 57. American Academy of Pediatrics, using nitrous oxide/oxygen (50:50) in for providing high-quality care. Pediatr American Academy of Pediatric the pediatric surgery emergency room: Radiol. 2011;41(suppl 2):517–522 Dentistry. Guidelines on the elective effectiveness and limitations. Eur J use of minimal, moderate, and deep 48. Andolfatto G, Willman E. A Pediatr Surg. 2015;25(3):250–256 sedation and general anesthesia prospective case series of pediatric for pediatric dental patients. 2011. 37. Hoyle JD Jr, Callahan JM, Badawy M, procedural sedation and analgesia Available at: http:// www. aapd. org/ et al; Traumatic Brain Injury Study in the emergency department using media/ policies_ guidelines/ g_ sedation. Group for the Pediatric Emergency single-syringe ketamine-propofol pdf. Accessed May 27, 2016 Care Applied Research Network combination (ketofol). Acad Emerg 58. Coté CJ, Wilson S; American Academy (PECARN). Pharmacological sedation Med. 2010;17(2):194–201 of Pediatrics; American Academy of for cranial computed tomography in 49. Brown SC, Hart G, Chastain DP, Pediatric Dentistry; Work Group on children after minor blunt head trauma. Schneeweiss S, McGrath PA. Reducing Sedation. Guidelines for monitoring Pediatr Emerg Care. 2014;30(1):1–7 distress for children during invasive and management of pediatric 38. Chiaretti A, Benini F, Pierri F, et al. procedures: randomized clinical trial patients during and after sedation Safety and effi cacy of propofol of effectiveness of the PediSedate. for diagnostic and therapeutic administered by paediatricians during Paediatr Anaesth. 2009;19(8):725–731 procedures: an update. Pediatrics. procedural sedation in children. Acta 50. Yamamoto LG. Initiating a hospital-wide 2006;118(6):2587–2602 Paediatr. 2014;103(2):182–187 pediatric sedation service provided 59. The Joint Commission. Comprehensive by emergency physicians. Clin Pediatr 39. Pacheco GS, Ferayorni A. Pediatric Accreditation Manual for Hospitals (Phila). 2008;47(1):37–48 procedural sedation and analgesia. (CAMH): the offi cial handbook. Emerg Med Clin North Am. 51. Doyle L, Colletti JE. Pediatric Oakbrook Terrace, IL: The Joint 2013;31(3):831–852 procedural sedation and Commission; 2014 analgesia. Pediatr Clin North Am. 60. American Society of Anesthesiologists 40. Griffi ths MA, Kamat PP, McCracken 2006;53(2):279–292 Task Force on Sedation and CE, Simon HK. Is procedural sedation Analgesia by Non-Anesthesiologists. with propofol acceptable for complex 52. Todd DW. Pediatric sedation and Practice guidelines for sedation and imaging? A comparison of short vs. anesthesia for the oral surgeon. analgesia by non-anesthesiologists. prolonged sedations in children. Oral Maxillofac Surg Clin North Am. Anesthesiology. 2002;96(4):1004–1017 Pediatr Radiol. 2013;43(10):1273–1278 2013;25(3):467–478, vi–vii 61. Committee of Origin: Ad Hoc on 41. Doctor K, Roback MG, Teach SJ. 53. Committee on Drugs, Section on Non-Anesthesiologist Privileging. An update on pediatric hospital- Anesthesiology, American Academy of Statement on granting privileges for based sedation. Curr Opin Pediatr. Pediatrics. Guidelines for the elective deep sedation to non-anesthesiologist 2013;25(3):310–316 use of conscious sedation, deep sedation practitioners. 2010. Available sedation, and general anesthesia at: http://www. asahq. org/ ~/ media/ 42. Alletag MJ, Auerbach MA, Baum CR. in pediatric patients. Pediatrics. sites/ asahq/ fi les/ public/ resources/ Ketamine, propofol, and ketofol use 1985;76(2):317–321 standards- guidelines/ advisory- on- for pediatric sedation. Pediatr Emerg granting- privileges- for- deep- sedation- Care. 2012;28(12):1391–1395; quiz: 54. American Academy of Pediatric to- non- anesthesiologist. pdf. Accessed 1396–1398 Dentistry. Guidelines for the elective use of conscious sedation, deep May 27, 2016 43. Jain R, Petrillo-Albarano T, Parks WJ, sedation, and general anesthesia in 62. Coté CJ, Karl HW, Notterman DA, Linzer JF Sr, Stockwell JA. Effi cacy pediatric patients. ASDC J Dent Child. Weinberg JA, McCloskey C. Adverse and safety of deep sedation by 1986;53(1):21–22 sedation events in pediatrics: analysis non-anesthesiologists for cardiac 55. Committee on Drugs, American of medications used for sedation. MRI in children. Pediatr Radiol. Pediatrics. 2000;106(4):633–644 2013;43(5):605–611 Academy of Pediatrics. Guidelines for monitoring and management 63. Coté CJ, Notterman DA, Karl HW, 44. Nelson T, Nelson G. The role of sedation of pediatric patients during and Weinberg JA, McCloskey C. Adverse in contemporary pediatric dentistry. after sedation for diagnostic and sedation events in pediatrics: a critical Dent Clin North Am. 2013;57(1):145–161 therapeutic procedures. Pediatrics. incident analysis of contributing 1992;89(6 pt 1):1110–1115 45. Monroe KK, Beach M, Reindel R, factors. Pediatrics. 2000;105(4 pt et al. Analysis of procedural sedation 56. Committee on Drugs, American 1):805–814 provided by pediatricians. Pediatr Int. Academy of Pediatrics. Guidelines 64. Kim G, Green SM, Denmark TK, Krauss 2013;55(1):17–23 for monitoring and management B. Ventilatory response during

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e17 dissociative sedation in children-a department. Pediatr Emerg Care. 87. Coté CJ. “Conscious sedation”: time for pilot study. Acad Emerg Med. 2001;17(2):115–122; quiz: 123–125 this oxymoron to go away! J Pediatr. 2003;10(2):140–145 76. Slovis TL. Sedation and anesthesia 2001;139(1):15–17; discussion: 18–19 65. Coté CJ. Sedation for the pediatric issues in pediatric imaging. Pediatr 88. Motas D, McDermott NB, VanSickle T, patient: a review. Pediatr Clin North Radiol. 2011;41(suppl 2):514–516 Friesen RH. Depth of consciousness Am. 1994;41(1):31–58 77. Babl FE, Krieser D, Belousoff J, and deep sedation attained in children as administered by 66. Mason KP, Burrows PE, Dorsey MM, Theophilos T. Evaluation of a paediatric nonanaesthesiologists in a children’s Zurakowski D, Krauss B. Accuracy procedural sedation training hospital. Paediatr Anaesth. of capnography with a 30 foot and credentialing programme: 2004;14(3):256–260 nasal cannula for monitoring sustainability of change. Emerg Med J. respiratory rate and end-tidal CO2 2010;27(8):577–581 89. Cudny ME, Wang NE, Bardas SL, Nguyen in children. J Clin Monit Comput. 78. Meredith JR, O’Keefe KP, Galwankar CN. Adverse events associated with 2000;16(4):259–262 S. Pediatric procedural sedation and procedural sedation in pediatric patients in the emergency department. 67. McQuillen KK, Steele DW. analgesia. J Emerg Trauma Shock. Hosp Pharm. 2013;48(2):134–142 Capnography during sedation/ 2008;1(2):88–96 analgesia in the pediatric emergency 79. Priestley S, Babl FE, Krieser D, et al. 90. Mora Capín A, Míguez Navarro C, department. Pediatr Emerg Care. Evaluation of the impact of a paediatric López López R, Marañón Pardillo 2000;16(6):401–404 procedural sedation credentialing R. Usefulness of capnography for 68. Malviya S, Voepel-Lewis T, Tait AR. programme on quality of care. Emerg monitoring sedoanalgesia: inﬂ uence of Adverse events and risk factors Med Australas. 2006;18(5–6):498–504 oxygen on the parameters monitored associated with the sedation of [in Spanish]. An Pediatr (Barc). 80. Babl F, Priestley S, Krieser D, et al. 2014;80(1):41–46 children by nonanesthesiologists. Development and implementation Anesth Analg. 1997;85(6):1207–1213 of an education and credentialing 91. Frieling T, Heise J, Kreysel C, Kuhlen 69. Coté CJ, Rolf N, Liu LM, et al. A programme to provide safe paediatric R, Schepke M. Sedation-associated single-blind study of combined pulse procedural sedation in emergency complications in endoscopy— oximetry and capnography in children. departments. Emerg Med Australas. prospective multicentre survey of Anesthesiology. 1991;74(6):980–987 2006;18(5–6):489–497 191142 patients. Z Gastroenterol. 2013;51(6):568–572 70. Guideline SIGN; Scottish Intercollegiate 81. Cravero JP, Blike GT. Pediatric Guidelines Network. SIGN Guideline sedation. Curr Opin Anaesthesiol. 92. Khutia SK, Mandal MC, Das S, Basu 58: safe sedation of children 2004;17(3):247–251 SR. Intravenous infusion of ketamine- undergoing diagnostic and therapeutic propofol can be an alternative to 82. Shavit I, Keidan I, Augarten A. The intravenous infusion of fentanyl- procedures. Paediatr Anaesth. practice of pediatric procedural 2008;18(1):11–12 propofol for deep sedation and sedation and analgesia in the analgesia in paediatric patients 71. Peña BM, Krauss B. Adverse events of emergency department. Eur J Emerg undergoing emergency short surgical procedural sedation and analgesia in a Med. 2006;13(5):270–275 procedures. Indian J Anaesth. pediatric emergency department. Ann 83. Langhan ML, Mallory M, Hertzog J, 2012;56(2):145–150 Emerg Med. 1999;34(4 pt 1):483–491 Lowrie L, Cravero J; Pediatric Sedation 93. Kannikeswaran N, Chen X, Sethuraman Research Consortium. Physiologic 72. Smally AJ, Nowicki TA. Sedation in the U. Utility of endtidal carbon dioxide monitoring practices during pediatric emergency department. Curr Opin monitoring in detection of hypoxia procedural sedation: a report from Anaesthesiol. 2007;20(4):379–383 during sedation for brain magnetic the Pediatric Sedation Research 73. Ratnapalan S, Schneeweiss S. resonance imaging in children with Consortium. Arch Pediatr Adolesc Med. Guidelines to practice: the process of developmental disabilities. Paediatr 2012;166(11):990–998 planning and implementing a pediatric Anaesth. 2011;21(12):1241–1246 sedation program. Pediatr Emerg 84. Primosch RE. Lidocaine toxicity in 94. McGrane O, Hopkins G, Nielson A, Care. 2007;23(4):262–266 children—prevention and intervention. Kang C. Procedural sedation with Todays FDA. 1992;4:4C–5C 74. Hoffman GM, Nowakowski R, Troshynski propofol: a retrospective review of the TJ, Berens RJ, Weisman SJ. Risk 85. Dial S, Silver P, Bock K, Sagy M. experiences of an emergency medicine reduction in pediatric procedural Pediatric sedation for procedures residency program 2005 to 2010. Am J sedation by application of an American titrated to a desired degree of Emerg Med. 2012;30(5):706–711 Academy of Pediatrics/American immobility results in unpredictable 95. Mallory MD, Baxter AL, Yanosky Society of Anesthesiologists process depth of sedation. Pediatr Emerg Care. DJ, Cravero JP; Pediatric Sedation model. Pediatrics. 2002;109(2):236–243 2001;17(6):414–420 Research Consortium. Emergency 75. Krauss B. Management of acute pain 86. Maxwell LG, Yaster M. The myth of physician-administered propofol and anxiety in children undergoing conscious sedation. Arch Pediatr sedation: a report on 25, 433 sedations procedures in the emergency Adolesc Med. 1996;150(7):665–667 from the Pediatric Sedation Research

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e18 FROM THE AMERICAN ACADEMY OF PEDIATRICS Consortium. Ann Emerg Med. discharge after intramuscular versus 113. Moore PA, Goodson JM. Risk appraisal 2011;57(5):462–468.e1 intravenous administration. Acad of narcotic sedation for children. 96. Langhan ML, Chen L, Marshall Emerg Med. 2009;16(2):101–107 Anesth Prog. 1985;32(4):129–139 C, Santucci KA. Detection of 105. Vardy JM, Dignon N, Mukherjee N, 114. Nahata MC, Clotz MA, Krogg EA. Adverse hypoventilation by capnography Sami DM, Balachandran G, Taylor S. effects of meperidine, promethazine, and its association with hypoxia Audit of the safety and effectiveness and chlorpromazine for sedation in in children undergoing sedation of ketamine for procedural sedation pediatric patients. Clin Pediatr (Phila). with ketamine. Pediatr Emerg Care. in the emergency department. Emerg 1985;24(10):558–560 2011;27(5):394–397 Med J. 2008;25(9):579–582 115. Brown ET, Corbett SW, Green SM. 97. David H, Shipp J. A randomized 106. Capapé S, Mora E, Mintegui S, García Iatrogenic cardiopulmonary arrest controlled trial of ketamine/propofol S, Santiago M, Benito J. Prolonged during pediatric sedation with versus propofol alone for emergency sedation and airway complications meperidine, promethazine, and department procedural sedation. Ann after administration of an inadvertent chlorpromazine. Pediatr Emerg Care. Emerg Med. 2011;57(5):435–441 ketamine overdose in emergency 2001;17(5):351–353 98. Babl FE, Belousoff J, Deasy C, Hopper department. Eur J Emerg Med. 116. Benusis KP, Kapaun D, Furnam LJ. S, Theophilos T. Paediatric procedural 2008;15(2):92–94 Respiratory depression in a child sedation based on nitrous oxide 107. Babl FE, Oakley E, Seaman C, Barnett following meperidine, promethazine, and ketamine: sedation registry P, Sharwood LN. High-concentration and chlorpromazine premedication: data from Australia. Emerg Med J. nitrous oxide for procedural sedation report of case. ASDC J Dent Child. 2010;27(8):607–612 in children: adverse events and depth 1979;46(1):50–53 99. Lee-Jayaram JJ, Green A, Siembieda of sedation. Pediatrics. 2008;121(3). 117. Garriott JC, Di Maio VJ. Death in the J, et al. Ketamine/midazolam versus Available at: www.pediatrics. org/ cgi/ dental chair: three drug fatalities in etomidate/fentanyl: procedural content/ full/ 121/ 3/ e528 dental patients. J Toxicol Clin Toxicol. sedation for pediatric orthopedic 108. Mahar PJ, Rana JA, Kennedy CS, 1982;19(9):987–995 reductions. Pediatr Emerg Care. Christopher NC. A randomized 118. Goodson JM, Moore PA. Life- 2010;26(6):408–412 clinical trial of oral transmucosal threatening reactions after pedodontic 100. Melendez E, Bachur R. Serious adverse fentanyl citrate versus intravenous sedation: an assessment of narcotic, events during procedural sedation morphine sulfate for initial control local anesthetic, and antiemetic with ketamine. Pediatr Emerg Care. of pain in children with extremity drug interaction. J Am Dent Assoc. 2009;25(5):325–328 injuries. Pediatr Emerg Care. 1983;107(2):239–245 2007;23(8):544–548 101. Misra S, Mahajan PV, Chen X, 119. Jastak JT, Pallasch T. Death 109. Sacchetti A, Stander E, Ferguson N, Kannikeswaran N. Safety of procedural after chloral hydrate sedation: Maniar G, Valko P. Pediatric Procedural sedation and analgesia in children report of case. J Am Dent Assoc. Sedation in the Community Emergency less than 2 years of age in a pediatric 1988;116(3):345–348 Department: results from the emergency department. Int J Emerg 120. Jastak JT, Peskin RM. Major ProSCED registry. Pediatr Emerg Care. Med. 2008;1(3):173–177 morbidity or mortality from ofﬁ ce 2007;23(4):218–222 anesthetic procedures: a closed-claim 102. Green SM, Roback MG, Krauss B, et al; 110. Anderson JL, Junkins E, Pribble analysis of 13 cases. Anesth Prog. Emergency Department Ketamine C, Guenther E. Capnography and 1991;38(2):39–44 Meta-Analysis Study Group. Predictors depth of sedation during propofol 121. Kaufman E, Jastak JT. Sedation of airway and respiratory adverse sedation in children. Ann Emerg Med. for outpatient dental procedures. events with ketamine sedation in 2007;49(1):9–13 the emergency department: an Compend Contin Educ Dent. individual-patient data meta-analysis 111. Luhmann JD, Schootman M, Luhmann 1995;16(5):462–466; quiz: 480 SJ, Kennedy RM. A randomized of 8,282 children. Ann Emerg Med. 122. Wilson S. Pharmacological comparison of nitrous oxide plus 2009;54(2):158–168.e1–e4 management of the pediatric hematoma block versus ketamine plus dental patient. Pediatr Dent. 103. Kannikeswaran N, Mahajan PV, midazolam for emergency department 2004;26(2):131–136 Sethuraman U, Groebe A, Chen X. forearm fracture reduction in children. Sedation medication received and Pediatrics. 2006;118(4). Available at: 123. Sams DR, Thornton JB, Wright adverse events related to sedation for www.pediatrics. org/ cgi/ content/ full/ JT. The assessment of two oral brain MRI in children with and without 118/ 4/ e1078 sedation drug regimens in pediatric developmental disabilities. Paediatr dental patients. ASDC J Dent Child. 112. Waterman GD Jr, Leder MS, Cohen DM. Anaesth. 2009;19(3):250–256 1992;59(4):306–312 Adverse events in pediatric ketamine 104. Ramaswamy P, Babl FE, Deasy C, sedations with or without morphine 124. Geelhoed GC, Landau LI, Le Souëf PN. Sharwood LN. Pediatric procedural pretreatment. Pediatr Emerg Care. Evaluation of SaO2 as a predictor of sedation with ketamine: time to 2006;22(6):408–411 outcome in 280 children presenting

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e19 with acute asthma. Ann Emerg Med. 134. Scherrer PD, Mallory MD, Cravero JP, in pediatric laceration repair: a 1994;23(6):1236–1241 Lowrie L, Hertzog JH, Berkenbosch preliminary report. Pediatr Emerg JW; Pediatric Sedation Research Care. 2012;28(8):767–770 125. Chicka MC, Dembo JB, Mathu-Muju Consortium. The impact of obesity on KR, Nash DA, Bush HM. Adverse events 144. Jasiak KD, Phan H, Christich AC, pediatric procedural sedation-related during pediatric dental anesthesia Edwards CJ, Skrepnek GH, Patanwala outcomes: results from the Pediatric and sedation: a review of closed AE. Induction dose of propofol for Sedation Research Consortium. malpractice insurance claims. Pediatr pediatric patients undergoing Paediatr Anaesth. 2015;25(7):689–697 Dent. 2012;34(3):231–238 procedural sedation in the emergency 135. Emrath ET, Stockwell JA, McCracken CE, department. Pediatr Emerg Care. 126. Lee HH, Milgrom P, Starks H, Burke Simon HK, Kamat PP. Provision of deep 2012;28(5):440–442 W. Trends in death associated with procedural sedation by a pediatric pediatric dental sedation and general 145. McMorrow SP, Abramo TJ. sedation team at a freestanding anesthesia. Paediatr Anaesth. Dexmedetomidine sedation: uses in imaging center. Pediatr Radiol. 2013;23(8):741–746 pediatric procedural sedation outside 2014;44(8):1020–1025 the operating room. Pediatr Emerg 127. Sanborn PA, Michna E, Zurakowski 136. Kamat PP, McCracken CE, Gillespie Care. 2012;28(3):292–296 D, et al. Adverse cardiovascular SE, et al. Pediatric critical care and respiratory events during physician-administered procedural 146. Sahyoun C, Krauss B. Clinical sedation of pediatric patients for sedation using propofol: a report implications of pharmacokinetics and imaging examinations. Radiology. from the Pediatric Sedation Research pharmacodynamics of procedural 2005;237(1):288–294 Consortium Database. Pediatr Crit sedation agents in children. Curr Opin Pediatr. 2012;24(2):225–232 128. Shavit I, Keidan I, Hoffmann Y, et al. Care Med. 2015;16(1):11–20 Enhancing patient safety during 147. Sacchetti A, Jachowski J, Heisler 137. Couloures KG, Beach M, Cravero pediatric sedation: the impact J, Cortese T. Remifentanil use in JP, Monroe KK, Hertzog JH. Impact of simulation-based training of emergency department patients: of provider specialty on pediatric nonanesthesiologists. Arch Pediatr initial experience. Emerg Med J. procedural sedation complication Adolesc Med. 2007;161(8):740–743 2012;29(11):928–929 rates. Pediatrics. 2011;127(5). Available 129. Cravero JP, Beach ML, Blike GT, at: www.pediatrics. org/ cgi/ content/ 148. Shah A, Mosdossy G, McLeod S, Gallagher SM, Hertzog JH; Pediatric full/ 127/ 5/ e1154 Lehnhardt K, Peddle M, Rieder M. Sedation Research Consortium. The A blinded, randomized controlled 138. Metzner J, Domino KB. Risks of incidence and nature of adverse trial to evaluate ketamine/propofol anesthesia or sedation outside events during pediatric sedation/ versus ketamine alone for procedural the operating room: the role of the anesthesia with propofol for sedation in children. Ann Emerg Med. anesthesia care provider. Curr Opin procedures outside the operating 2011;57(5):425–433.e2 Anaesthesiol. 2010;23(4):523–531 room: a report from the Pediatric 149. Herd DW, Anderson BJ, Keene Sedation Research Consortium. Anesth 139. Patel KN, Simon HK, Stockwell CA, NA, Holford NH. Investigating the Analg. 2009;108(3):795–804 et al. Pediatric procedural sedation pharmacodynamics of ketamine by a dedicated nonanesthesiology 130. Blike GT, Christoffersen K, Cravero JP, in children. Paediatr Anaesth. pediatric sedation service using Andeweg SK, Jensen J. A method for 2008;18(1):36–42 propofol. Pediatr Emerg Care. measuring system safety and latent 2009;25(3):133–138 150. Sharieff GQ, Trocinski DR, Kanegaye JT, errors associated with pediatric Fisher B, Harley JR. Ketamine-propofol procedural sedation. Anesth Analg. 140. Koo SH, Lee DG, Shin H. Optimal initial combination sedation for fracture 2005;101(1):48–58 dose of chloral hydrate in management reduction in the pediatric emergency of pediatric facial laceration. Arch 131. Cravero JP, Havidich JE. Pediatric department. Pediatr Emerg Care. Plast Surg. 2014;41(1):40–44 sedation—evolution and revolution. 2007;23(12):881–884 Paediatr Anaesth. 2011;21(7):800–809 141. Ivaturi V, Kriel R, Brundage R, Loewen 151. Herd DW, Anderson BJ, Holford NH. G, Mansbach H, Cloyd J. Bioavailability 132. Havidich JE, Cravero JP. The current Modeling the norketamine metabolite of intranasal vs. rectal diazepam. status of procedural sedation in children and the implications Epilepsy Res. 2013;103(2–3):254–261 for pediatric patients in out-of- for analgesia. Paediatr Anaesth. operating room locations. Curr Opin 142. Mandt MJ, Roback MG, Bajaj L, Galinkin 2007;17(9):831–840 Anaesthesiol. 2012;25(4):453–460 JL, Gao D, Wathen JE. Etomidate for 152. Herd D, Anderson BJ. Ketamine short pediatric procedures in the disposition in children presenting for 133. Hollman GA, Banks DM, emergency department. Pediatr Emerg procedural sedation and analgesia in Berkenbosch JW, et al. Development, Care. 2012;28(9):898–904 a children’s emergency department. implementation, and initial participant Paediatr Anaesth. 2007;17(7):622–629 feedback of a pediatric sedation 143. Tsze DS, Steele DW, Machan JT, provider course. Teach Learn Med. Akhlaghi F, Linakis JG. Intranasal 153. Heard CM, Joshi P, Johnson K. 2013;25(3):249–257 ketamine for procedural sedation Dexmedetomidine for pediatric MRI

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e20 FROM THE AMERICAN ACADEMY OF PEDIATRICS sedation: a review of a series of cases. Effects of IV pentobarbital with using propofol: analysis of the nature, Paediatr Anaesth. 2007;17(9):888–892 and without fentanyl on end-tidal frequency, and predictors of adverse carbon dioxide levels during deep events and interventions. J Pediatr. 154. Heard C, Burrows F, Johnson K, Joshi sedation of pediatric patients 2012;160(5):801–806.e1 P, Houck J, Lerman J. A comparison undergoing MRI. AJR Am J Roentgenol. of dexmedetomidine-midazolam 174. Langhan ML, Shabanova V, Li FY, 2003;181(6):1691–1694 with propofol for maintenance of Bernstein SL, Shapiro ED. A randomized anesthesia in children undergoing 164. Primosch RE, Buzzi IM, Jerrell G. controlled trial of capnography magnetic resonance imaging. Anesth Monitoring pediatric dental patients during sedation in a pediatric Analg. 2008;107(6):1832–1839 with nasal mask capnography. Pediatr emergency setting. Am J Emerg Med. Dent. 2000;22(2):120–124 2015;33(1):25–30 155. Hertzog JH, Havidich JE. Non- anesthesiologist-provided pediatric 165. Tobias JD. End-tidal carbon dioxide 175. Vetri Buratti C, Angelino F, Sansoni procedural sedation: an update. Curr monitoring during sedation with J, Fabriani L, Mauro L, Latina R. Opin Anaesthesiol. 2007;20(4):365–372 a combination of midazolam and Distraction as a technique to ketamine for children undergoing control pain in pediatric patients 156. Petroz GC, Sikich N, James M, painful, invasive procedures. Pediatr during venipuncture: a narrative et al. A phase I, two-center Emerg Care. 1999;15(3):173–175 review of literature. Prof Inferm. study of the pharmacokinetics 2015;68(1):52–62 and pharmacodynamics of 166. Hart LS, Berns SD, Houck CS, dexmedetomidine in children. Boenning DA. The value of end-tidal 176. Robinson PS, Green J. Ambient versus Anesthesiology. 2006;105(6):1098–1110 CO2 monitoring when comparing traditional environment in pediatric emergency department. HERD. 157. Potts AL, Anderson BJ, Warman three methods of conscious sedation 2015;8(2):71–80 GR, Lerman J, Diaz SM, Vilo S. for children undergoing painful Dexmedetomidine pharmacokinetics procedures in the emergency 177. Singh D, Samadi F, Jaiswal J, Tripathi in pediatric intensive care—a department. Pediatr Emerg Care. AM. Stress reduction through audio pooled analysis. Paediatr Anaesth. 1997;13(3):189–193 distraction in anxious pediatric 2009;19(11):1119–1129 167. Marx CM, Stein J, Tyler MK, Nieder dental patients: an adjunctive ML, Shurin SB, Blumer JL. Ketamine- clinical study. Int J Clin Pediatr Dent. 158. Mason KP, Lerman J. Dexmedetomidine 2014;7(3):149–152 in children: current knowledge and midazolam versus meperidine- future applications [review]. Anesth midazolam for painful procedures 178. Attar RH, Baghdadi ZD. Comparative Analg. 2011;113(5):1129–1142 in pediatric oncology patients. J Clin efﬁ cacy of active and passive Oncol. 1997;15(1):94–102 distraction during restorative 159. Sammartino M, Volpe B, Sbaraglia F, 168. Croswell RJ, Dilley DC, Lucas WJ, Vann treatment in children using an iPad Garra R, D'Addessi A. Capnography versus audiovisual eyeglasses: a and the bispectral index—their role in WF Jr. A comparison of conventional versus electronic monitoring of randomised controlled trial. Eur Arch pediatric sedation: a brief review. Int J Paediatr Dent. 2015;16(1):1–8 Pediatr. 2010;2010:828347 sedated pediatric dental patients. Pediatr Dent. 1995;17(5):332–339 179. McCarthy AM, Kleiber C, Hanrahan K, 160. Yarchi D, Cohen A, Umansky T, 169. Iwasaki J, Vann WF Jr, Dilley DC, et al. Matching doses of distraction with Sukhotnik I, Shaoul R. Assessment Anderson JA. An investigation of child risk for distress during a medical of end-tidal carbon dioxide during capnography and pulse oximetry as procedure: a randomized clinical trial. pediatric and adult sedation for monitors of pediatric patients sedated Nurs Res. 2014;63(6):397–407 endoscopic procedures. Gastrointest for dental treatment. Pediatr Dent. Endosc. 2009;69(4):877–882 180. Guinot Jimeno F, Mercadé Bellido 1989;11(2):111–117 M, Cuadros Fernández C, Lorente 161. Lightdale JR, Goldmann DA, Feldman Rodríguez AI, Llopis Pérez J, Boj 170. Anderson JA, Vann WF Jr. Respiratory HA, Newburg AR, DiNardo JA, Fox VL. Quesada JR. Effect of audiovisual monitoring during pediatric sedation: Microstream capnography improves distraction on children’s behaviour, pulse oximetry and capnography. patient monitoring during moderate anxiety and pain in the dental Pediatr Dent. 1988;10(2):94–101 sedation: a randomized, controlled setting. Eur J Paediatr Dent. trial. Pediatrics. 2006;117(6). Available 171. Rothman DL. Sedation of the 2014;15(3):297–302 at: www.pediatrics. org/ cgi/ content/ pediatric patient. J Calif Dent Assoc. 181. Gupta HV, Gupta VV, Kaur A, et al. full/117/ 6/ e1170 2013;41(8):603–611 Comparison between the analgesic 162. Yldzda ş D, Yapcoglu H, Ylmaz HL. The 172. Scherrer PD. Safe and sound: pediatric effect of two techniques on the level of value of capnography during sedation procedural sedation and analgesia. pain perception during venipuncture in or sedation/analgesia in pediatric Minn Med. 2011;94(3):43–47 children up to 7 years of age: a quasi- minor procedures. Pediatr Emerg experimental study. J Clin Diagn Res. 173. Srinivasan M, Turmelle M, Depalma Care. 2004;20(3):162–165 2014;8(8):PC01–PC04 LM, Mao J, Carlson DW. Procedural 163. Connor L, Burrows PE, Zurakowski sedation for diagnostic imaging in 182. Newton JT, Shah S, Patel H, Sturmey P. D, Bucci K, Gagnon DA, Mason KP. children by pediatric hospitalists Non-pharmacological approaches to

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e21 behaviour management in children. Network (DirecNet) experience. Pediatr clinical trial. J Dent Res Dent Clin Dent Dent Update. 2003;30(4):194–199 Radiol. 2014;44(2):181–186 Prospect. 2012;6(4):117–124 183. Peretz B, Bimstein E. The use 194. Ram D, Shapira J, Holan G, Magora 204. El-Sharkawi HF, El-Housseiny of imagery suggestions during F, Cohen S, Davidovich E. Audiovisual AA, Aly AM. Effectiveness of new administration of local anesthetic in video eyeglass distraction during distraction technique on pain pediatric dental patients. ASDC J Dent dental treatment in children. associated with injection of local Child. 2000;67(4):263–267, 231 Quintessence Int. 2010;41(8): anesthesia for children. Pediatr Dent. 2012;34(2):e35–e38 184. Iserson KV. Hypnosis for pediatric 673–679 fracture reduction. J Emerg Med. 195. Lemaire C, Moran GR, Swan H. Impact 205. Adinolfi B, Gava N. Controlled outcome 1999;17(1):53–56 of audio/visual systems on pediatric studies of child clinical hypnosis. Acta Biomed. 2013;84(2):94–97 185. Rusy LM, Weisman SJ. Complementary sedation in magnetic resonance therapies for acute pediatric pain imaging. J Magn Reson Imaging. 206. Peretz B, Bercovich R, Blumer S. management. Pediatr Clin North Am. 2009;30(3):649–655 Using elements of hypnosis prior to 2000;47(3):589–599 196. Nordahl CW, Simon TJ, Zierhut C, or during pediatric dental treatment. Pediatr Dent. 2013;35(1):33–36 186. Langley P. Guided imagery: a review of Solomon M, Rogers SJ, Amaral DG. effectiveness in the care of children. Brief report: methods for acquiring 207. Huet A, Lucas-Polomeni MM, Paediatr Nurs. 1999;11(3):18–21 structural MRI data in very young Robert JC, Sixou JL, Wodey E. children with autism without the use Hypnosis and dental anesthesia in 187. Ott MJ. Imagine the possibilities! of sedation. J Autism Dev Disord. children: a prospective controlled Guided imagery with toddlers 2008;38(8):1581–1590 study. Int J Clin Exp Hypn. and pre-schoolers. Pediatr Nurs. 2011;59(4):424–440 1996;22(1):34–38 197. Denman WT, Tuason PM, Ahmed MI, Brennen LM, Cepeda MS, Carr 208. Al-Harasi S, Ashley PF, Moles DR, 188. Singer AJ, Stark MJ. LET versus DB. The PediSedate device, a novel Parekh S, Walters V. Hypnosis for EMLA for pretreating lacerations: a approach to pediatric sedation that children undergoing dental treatment. randomized trial. Acad Emerg Med. provides distraction and inhaled Cochrane Database Syst Rev. 2001;8(3):223–230 nitrous oxide: clinical evaluation in a 2010;8:CD007154 large case series. Paediatr Anaesth. 189. Taddio A, Gurguis MG, Koren G. 209. McQueen A, Cress C, Tothy A. Using 2007;17(2):162–166 Lidocaine-prilocaine cream versus a tablet computer during pediatric tetracaine gel for procedural pain 198. Harned RK II, Strain JD. MRI-compatible procedures: a case series and review in children. Ann Pharmacother. audio/visual system: impact on of the “apps”. Pediatr Emerg Care. 2002;36(4):687–692 pediatric sedation. Pediatr Radiol. 2012;28(7):712–714 2001;31(4):247–250 190. Eichenfi eld LF, Funk A, Fallon- 210. Heilbrunn BR, Wittern RE, Lee JB, Pham Friedlander S, Cunningham BB. A 199. Slifer KJ. A video system to help PK, Hamilton AH, Nager AL. Reducing clinical study to evaluate the effi cacy children cooperate with motion anxiety in the pediatric emergency of ELA-Max (4% liposomal lidocaine) control for radiation treatment department: a comparative trial. as compared with eutectic mixture without sedation. J Pediatr Oncol Nurs. J Emerg Med. 2014;47(6):623–631 of local anesthetics cream for pain 1996;13(2):91–97 211. Tyson ME, Bohl DD, Blickman JG. A reduction of venipuncture in children. 200. Krauss BS, Krauss BA, Green SM. randomized controlled trial: child life Pediatrics. 2002;109(6):1093–1099 Videos in clinical medicine: procedural services in pediatric imaging. Pediatr 191. Shaw AJ, Welbury RR. The use of sedation and analgesia in children. Radiol. 2014;44(11):1426–1432 hypnosis in a sedation clinic for N Engl J Med. 2014;370(15):e23 212. Malviya S, Voepel-Lewis T, Tait AR, dental extractions in children: report 201. Wilson S. Management of child patient Merkel S, Tremper K, Naughton of 20 cases. ASDC J Dent Child. behavior: quality of care, fear and N. Depth of sedation in children 1996;63(6):418–420 anxiety, and the child patient. Pediatr undergoing computed tomography: 192. Stock A, Hill A, Babl FE. Practical Dent. 2013;35(2):170–174 validity and reliability of the communication guide for paediatric 202. Kamath PS. A novel distraction University of Michigan Sedation procedures. Emerg Med Australas. technique for pain management during Scale (UMSS). Br J Anaesth. 2012;24(6):641–646 local anesthesia administration in 2002;88(2):241–245 193. Barnea-Goraly N, Weinzimer SA, Ruedy pediatric patients. J Clin Pediatr Dent. 213. Gamble C, Gamble J, Seal R, Wright KJ, et al; Diabetes Research in Children 2013;38(1):45–47 RB, Ali S. Bispectral analysis during Network (DirecNet). High success rates 203. Asl Aminabadi N, Erfanparast L, procedural sedation in the pediatric of sedation-free brain MRI scanning in Sohrabi A, Ghertasi Oskouei S, emergency department. Pediatr Emerg young children using simple subject Naghili A. The impact of virtual reality Care. 2012;28(10):1003–1008 preparation protocols with and distraction on pain and anxiety during 214. Domino KB. Offi ce-based anesthesia: without a commercial mock scanner— dental treatment in 4-6 year-old lessons learned from the closed claims the Diabetes Research in Children children: a randomized controlled project. ASA Newsl. 2001;65:9–15

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e22 FROM THE AMERICAN ACADEMY OF PEDIATRICS 215. American Heart Association. Pediatric 225. Krauss B, Green SM. Sedation and Pharmacodynamic modeling of the Advance Life Support Provider Manual. analgesia for procedures in children. electroencephalographic effects Dallas, TX: American Heart Association; N Engl J Med. 2000;342(13):938–945 of midazolam and diazepam. Clin 2011 226. Ferrari L, ed . Anesthesia and Pain Pharmacol Ther. 1990;48(5):555–567 216. American Academy of Pediatrics, Management for the Pediatrician, 238. Malviya S, Voepel-Lewis T, Ludomirsky American College of Emergency 1st ed. Baltimore, MD: John Hopkins A, Marshall J, Tait AR. Can we Physicians. Advanced Pediatric Life University Press; 1999 improve the assessment of discharge Support, 5th ed.. Boston, MA: Jones 227. Malvyia S. Sedation Analgesia readiness? A comparative study of and Bartlett Publishers; 2012 for Diagnostic and Therapeutic observational and objective measures of depth of sedation in children. 217. Cheng A, Brown LL, Duff JP, et al; Procedures, 1st ed. Totowa, NJ: Anesthesiology. 2004;100(2):218–224 International Network for Simulation- Humana Press; 2001 239. Coté CJ. Discharge criteria for children Based Pediatric Innovation, 228. Yaster M, Krane EJ, Kaplan RF, Coté CJ, sedated by nonanesthesiologists: Research, and Education (INSPIRE) Lappe DG. Pediatric Pain Management is “safe” really safe enough? CPR Investigators. Improving and Sedation Handbook. 1st ed. St. Anesthesiology. 2004;100(2):207–209 cardiopulmonary resuscitation with Louis, MO: Mosby-Year Book, Inc.; 1997 a CPR feedback device and refresher 240. Pershad J, Palmisano P, Nichols 229. Cravero JP, Blike GT. Review of simulations (CPR CARES Study): a M. Chloral hydrate: the good and pediatric sedation. Anesth Analg. randomized clinical trial. JAMA Pediatr. the bad. Pediatr Emerg Care. 2004;99(5):1355–1364 2015;169(2):137–144 1999;15(6):432–435 230. Deshpande JK, Tobias JD. The Pediatric 218. Nishisaki A, Nguyen J, Colborn S, 241. McCormack L, Chen JW, Trapp L, Pain Handbook. 1st ed. St. Louis, MO: et al. Evaluation of multidisciplinary Job A. A comparison of sedation- Mosby; 1996 simulation training on clinical related events for two multiagent performance and team behavior 231. Mace SE, Barata IA, Cravero JP, et al; oral sedation regimens in pediatric during tracheal intubation American College of Emergency dental patients. Pediatr Dent. procedures in a pediatric intensive Physicians. Clinical policy: evidence- 2014;36(4):302–308 care unit. Pediatr Crit Care Med. based approach to pharmacologic 2011;12(4):406–414 242. Kinane TB, Murphy J, Bass JL, Corwin agents used in pediatric sedation MJ. Comparison of respiratory 219. Howard-Quijano KJ, Stiegler MA, and analgesia in the emergency physiologic features when infants are Huang YM, Canales C, Steadman department. Ann Emerg Med. placed in car safety seats or car beds. RH. Anesthesiology residents’ 2004;44(4):342–377 Pediatrics. 2006;118(2):522–527 performance of pediatric resuscitation 232. Alcaino EA. Conscious sedation 243. Wyeth Pharmaceuticals. Wyeth during a simulated hyperkalemic in paediatric dentistry: current Phenergan (Promethazine HCL) cardiac arrest. Anesthesiology. philosophies and techniques. Tablets and Suppositories [package 2010;112(4):993–997 Ann R Australas Coll Dent Surg. insert]. Philadelphia, PA: Wyeth 220. Chen MI, Edler A, Wald S, DuBois 2000;15:206–210 Pharmaceuticals; 2012 J, Huang YM. Scenario and 233. Tobias JD, Cravero JP. Procedural 244. Caperell K, Pitetti R. Is higher ASA checklist for airway rescue during Sedation for Infants, Children, and class associated with an increased pediatric sedation. Simul Healthc. Adolescents. Elk Grove Village, IL: incidence of adverse events during 2007;2(3):194–198 American Academy of Pediatrics; 2015 procedural sedation in a pediatric 221. Wheeler M. Management strategies for 234. Committee on Standards and Practice emergency department? Pediatr Emerg the difﬁ cult pediatric airway. In: Riazi J, Parameters. Standards for Basic Care. 2009;25(10):661–664 ed. The Difﬁ cult Pediatric Airway. 16th Anesthetic Monitoring. Chicago, IL: 245. Dar AQ, Shah ZA. Anesthesia and ed. Philadelphia, PA: W.B. Saunders American Society of Anesthesiologists; sedation in pediatric gastrointestinal Company; 1998:743–761 2011 endoscopic procedures: a review. 222. Sullivan KJ, Kissoon N. Securing 235. Mitchell AA, Louik C, Lacouture World J Gastrointest Endosc. the child’s airway in the emergency P, Slone D, Goldman P, Shapiro S. 2010;2(7):257–262 department. Pediatr Emerg Care. Risks to children from computed 246. Kiringoda R, Thurm AE, Hirschtritt 2002;18(2):108–121; quiz: tomographic scan premedication. ME, et al. Risks of propofol sedation/ 122–124 JAMA. 1982;247(17):2385–2388 anesthesia for imaging studies in 223. Levy RJ, Helfaer MA. Pediatric 236. Wolfe TR, Braude DA. Intranasal pediatric research: eight years of airway issues. Crit Care Clin. medication delivery for children: a experience in a clinical research 2000;16(3):489–504 brief review and update. Pediatrics. center. Arch Pediatr Adolesc Med. 224. Krauss B, Green SM. Procedural 2010;126(3):532–537 2010;164(6):554–560 sedation and analgesia in 237. Bührer M, Maitre PO, Crevoisier C, 247. Thakkar K, El-Serag HB, Mattek children. Lancet. 2006; Stanski DR. Electroencephalographic N, Gilger MA. Complications of 367(9512):766–780 effects of benzodiazepines. II. pediatric EGD: a 4-year experience

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e23 in PEDS-CORI. Gastrointest Endosc. in the UK: a prospective survey of sedation. Emerg Med Australas. 2007;65(2):213–221 specialist pediatric centers over a 2004;16(2):145–150 one-year period. Paediatr Anaesth. 248. Jackson DL, Johnson BS. Conscious 268. Pitetti RD, Singh S, Pierce MC. Safe and 2013;23(8):702–711 sedation for dentistry: risk efﬁ cacious use of procedural sedation management and patient selection. 259. Babl FE, Puspitadewi A, Barnett P, and analgesia by nonanesthesiologists Dent Clin North Am. 2002;46(4):767–780 Oakley E, Spicer M. Preprocedural in a pediatric emergency department. 249. Malviya S, Voepel-Lewis T, Eldevik OP, fasting state and adverse events Arch Pediatr Adolesc Med. Rockwell DT, Wong JH, Tait AR. Sedation in children receiving nitrous 2003;157(11):1090–1096 and general anaesthesia in children oxide for procedural sedation and 269. Thorpe RJ, Benger J. Pre-procedural undergoing MRI and CT: adverse analgesia. Pediatr Emerg Care. fasting in emergency sedation. Emerg events and outcomes. Br J Anaesth. 2005;21(11):736–743 Med J. 2010;27(4):254–261 2000;84(6):743–748 260. Roback MG, Bajaj L, Wathen JE, Bothner 250. O’Neil J, Yonkman J, Talty J, Bull MJ. J. Preprocedural fasting and adverse 270. Paris PM, Yealy DM. A procedural Transporting children with special events in procedural sedation and sedation and analgesia fasting health care needs: comparing analgesia in a pediatric emergency consensus advisory: one small step recommendations and practice. department: are they related? Ann for emergency medicine, one giant Pediatrics. 2009;124(2):596–603 Emerg Med. 2004;44(5):454–459 challenge remaining. Ann Emerg Med. 2007;49(4):465–467 251. Committee on Bioethics, American 261. Vespasiano M, Finkelstein M, Kurachek Academy of Pediatrics. Informed S. Propofol sedation: intensivists’ 271. American Society of Anesthesiologists consent, parental permission, and experience with 7304 cases in a Committee. Practice guidelines for assent in pediatric practice Pediatrics. children’s hospital. Pediatrics. preoperative fasting and the use 1995;95(2):314–317 2007;120(6). Available at: www. of pharmacologic agents to reduce 252. Committee on Pediatric Emergency pediatrics. org/ cgi/ content/ full/ 120/ 6/ the risk of pulmonary aspiration: Medicine; Committee on Bioethics. e1411 application to healthy patients undergoing elective procedures: Consent for emergency medical 262. Warner MA, Warner ME, Warner DO, an updated report by the American services for children and adolescents. Warner LO, Warner EJ. Perioperative Society of Anesthesiologists Pediatrics. 2011;128(2):427–433 pulmonary aspiration in infants Committee on Standards and and children. Anesthesiology. 253. Martinez D, Wilson S. Children sedated Practice Parameters. Anesthesiology. 1999;90(1):66–71 for dental care: a pilot study of the 2011;114(3):495–511 24-hour postsedation period. Pediatr 263. Borland LM, Sereika SM, Woelfel SK, 272. Mace SE, Brown LA, Francis L, et al Dent. 2006;28(3):260–264 et al. Pulmonary aspiration in pediatric Clinical policy: Critical issues in the 254. Kaila R, Chen X, Kannikeswaran N. patients during general anesthesia: sedation of pediatric patients in the Postdischarge adverse events related incidence and outcome. J Clin Anesth. emergency department. Ann Emerg to sedation for diagnostic imaging 1998;10(2):95–102 Med. 2008;51:378–399 in children. Pediatr Emerg Care. 2012;28(8):796–801 264. Agrawal D, Manzi SF, Gupta R, Krauss 273. Green SM, Roback MG, Miner JR, B. Preprocedural fasting state and 255. Treston G, Bell A, Cardwell R, Fincher G, Burton JH, Krauss B. Fasting and adverse events in children undergoing emergency department procedural Chand D, Cashion G. What is the nature procedural sedation and analgesia in a of the emergence phenomenon when sedation and analgesia: a consensus- pediatric emergency department. Ann based clinical practice advisory. Ann using intravenous or intramuscular Emerg Med. 2003;42(5):636–646 ketamine for paediatric procedural Emerg Med. 2007;49(4):454–461 sedation? Emerg Med Australas. 265. Green SM. Fasting is a consideration— 274. Duchicela S, Lim A. Pediatric 2009;21(4):315–322 not a necessity—for emergency nerve blocks: an evidence-based department procedural sedation 256. Malviya S, Voepel-Lewis T, Prochaska approach. Pediatr Emerg Med Pract. and analgesia. Ann Emerg Med. G, Tait AR. Prolonged recovery and 2013;10(10):1–19; quiz: 19–20 2003;42(5):647–650 delayed side effects of sedation for 275. Beach ML, Cohen DM, Gallagher SM, diagnostic imaging studies in children. 266. Green SM, Krauss B. Pulmonary Cravero JP. Major adverse events Pediatrics. 2000;105(3):E42 aspiration risk during emergency and relationship to nil per os status 257. Nordt SP, Rangan C, Hardmaslani department procedural sedation—an in pediatric sedation/anesthesia M, Clark RF, Wendler C, Valente M. examination of the role of fasting and outside the operating room: a Pediatric chloral hydrate poisonings sedation depth. Acad Emerg Med. report of the Pediatric Sedation and death following outpatient 2002;9(1):35–42 Research Consortium. Anesthesiology. 2016;124(1):80–88 procedural sedation. J Med Toxicol. 267. Treston G. Prolonged pre-procedure 2014;10(2):219–222 fasting time is unnecessary 276. Green SM, Krauss B. Ketamine is 258. Walker RW. Pulmonary aspiration when using titrated intravenous a safe, effective, and appropriate in pediatric anesthetic practice ketamine for paediatric procedural technique for emergency department

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e24 FROM THE AMERICAN ACADEMY OF PEDIATRICS paediatric procedural sedation. Emerg perforatum) on human cytochrome Altimiras J. Interactions of Valeriana Med J. 2004;21(3):271–272 P450 activity. Clin Pharmacol Ther. offi cinalis L. and Passifl ora incarnata 277. American Academy of Pediatrics 2001;70(4):317–326 L. in a patient treated with lorazepam. Committee on Pediatric Emergency 288. Xie HG, Kim RB. St John’s wort- Phytother Res. 2009;23(12):1795–1796 Medicine. The use of physical restraint associated drug interactions: 300. von Rosensteil NA, Adam D. Macrolide interventions for children and short-term inhibition and long-term antibacterials: drug interactions adolescents in the acute care setting. induction? Clin Pharmacol Ther. of clinical signifi cance. Drug Saf. Pediatrics. 1997;99(3):497–498 2005;78(1):19–24 1995;13(2):105–122 278. American Academy of Pediatrics 289. Chen XW, Sneed KB, Pan SY, et al. Herb- 301. Hiller A, Olkkola KT, Isohanni P, Committee on Child Abuse and drug interactions and mechanistic Saarnivaara L. Unconsciousness Neglect. Behavior management of and clinical considerations. Curr Drug associated with midazolam and pediatric dental patients. Pediatrics. Metab. 2012;13(5):640–651 erythromycin. Br J Anaesth. 1992;90(4):651–652 1990;65(6):826–828 290. Chen XW, Serag ES, Sneed KB, et al. 279. American Academy of Pediatric Clinical herbal interactions with 302. Mattila MJ, Idänpään-Heikkilä Dentistry. Guideline on protective conventional drugs: from molecules JJ, Törnwall M, Vanakoski J. Oral stabilization for pediatric to maladies. Curr Med Chem. single doses of erythromycin and dental patients. Pediatr Dent. 2011;18(31):4836–4850 roxithromycin may increase the effects 2013;35(5):E169–E173 of midazolam on human performance. 291. Shi S, Klotz U. Drug interactions with Pharmacol Toxicol. 1993;73(3):180–185 280. Loo CY, Graham RM, Hughes CV. herbal medicines. Clin Pharmacokinet. Behaviour guidance in dental 2012;51(2):77–104 303. Olkkola KT, Aranko K, Luurila H, treatment of patients with autism et al. A potentially hazardous spectrum disorder. Int J Paediatr Dent. 292. Saxena A, Tripathi KP, Roy S, Khan interaction between erythromycin 2009;19(6):390–398 F, Sharma A. Pharmacovigilance: and midazolam. Clin Pharmacol Ther. effects of herbal components on 1993;53(3):298–305 281. McWhorter AG, Townsend JA; American human drugs interactions involving Academy of Pediatric Dentistry. cytochrome P450. Bioinformation. 304. Senthilkumaran S, Subramanian Behavior symposium workshop A 2008;3(5):198–204 PT. Prolonged sedation related report—current guidelines/revision. to erythromycin and midazolam Pediatr Dent. 2014;36(2):152–153 293. Yang X, Salminen WF. Kava extract, an interaction: a word of caution. Indian herbal alternative for anxiety relief, Pediatr. 2011;48(11):909 282. American Society of Anesthesiologists potentiates acetaminophen-induced CoSaPP. Practice advisory for cytotoxicity in rat hepatic cells. 305. Flockhart DA, Oesterheld JR. preanesthesia evaluation an Phytomedicine. 2011;18(7):592–600 Cytochrome P450-mediated drug updated report by the American interactions. Child Adolesc Psychiatr Society of Anesthesiologists Task 294. Teschke R. Kava hepatotoxicity: Clin N Am. 2000;9(1):43–76 pathogenetic aspects and Force on Preanesthesia Evaluation. 306. Yuan R, Flockhart DA, Balian prospective considerations. Liver Int. Anesthesiology. 2012;116:1–17 JD. Pharmacokinetic and 2010;30(9):1270–1279 283. Gorski JC, Huang SM, Pinto A, et al. pharmacodynamic consequences of The effect of echinacea (Echinacea 295. Izzo AA, Ernst E. Interactions between metabolism-based drug interactions purpurea root) on cytochrome P450 herbal medicines and prescribed with alprazolam, midazolam, activity in vivo. Clin Pharmacol Ther. drugs: an updated systematic review. and triazolam. J Clin Pharmacol. 2004;75(1):89–100 Drugs. 2009;69(13):1777–1798 1999;39(11):1109–1125 284. Hall SD, Wang Z, Huang SM, et al. 296. Ang-Lee MK, Moss J, Yuan CS. Herbal 307. Young B. Review: mixing new cocktails: The interaction between St John’s medicines and perioperative care. drug interactions in antiretroviral wort and an oral contraceptive. Clin JAMA. 2001;286(2):208–216 regimens. AIDS Patient Care STDS. Pharmacol Ther. 2003;74(6):525–535 297. Abebe W. Herbal medication: potential 2005;19(5):286–297 285. Markowitz JS, Donovan JL, DeVane for adverse interactions with 308. Gonçalves LS, Gonçalves BM, de CL, et al. Effect of St John’s wort on analgesic drugs. J Clin Pharm Ther. Andrade MA, Alves FR, Junior AS. drug metabolism by induction of 2002;27(6):391–401 Drug interactions during periodontal cytochrome P450 3A4 enzyme. JAMA. Mini 298. Mooiman KD, Maas-Bakker RF, Hendrikx therapy in HIV-infected subjects. 2003;290(11):1500–1504 Rev Med Chem JJ, et al. The effect of complementary . 2010;10(8):766–772 286. Spinella M. Herbal medicines and and alternative medicines on CYP3A4- 309. Brown KC, Paul S, Kashuba AD. epilepsy: the potential for benefi t mediated metabolism of three different Drug interactions with new and and adverse effects. Epilepsy Behav. substrates: 7-benzyloxy-4-trifl uoromethyl- investigational antiretrovirals. Clin 2001;2(6):524–532 coumarin, midazolam and docetaxel. J Pharmacokinet. 2009;48(4):211–241 287. Wang Z, Gorski JC, Hamman MA, Pharm Pharmacol. 2014;66(6):865–874 310. Pau AK. Clinical management of drug Huang SM, Lesko LJ, Hall SD. The 299. Carrasco MC, Vallejo JR, Pardo-de- interaction with antiretroviral agents. effects of St John’s wort (Hypericum Santayana M, Peral D, Martín MA, Curr Opin HIV AIDS. 2008;3(3):319–324

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e25 311. Moyal WN, Lord C, Walkup JT. Quality and its metabolite morphine in ultra- 332. August DA, Everett LL. Pediatric of life in children and adolescents rapid metabolizers due to CYP2D6 ambulatory anesthesia. Anesthesiol with autism spectrum disorders: duplication. Pharmacogenomics J. Clin. 2014;32(2):411–429 what is known about the effects of 2007;7(4):257–265 333. Maxwell LG. Age-associated issues in pharmacotherapy? Paediatr Drugs. 323. Voronov P, Przybylo HJ, Jagannathan preoperative evaluation, testing, and 2014;16(2):123–128 N. Apnea in a child after oral codeine: planning: pediatrics. Anesthesiol Clin 312. van den Anker JN. Developmental a genetic variant—an ultra-rapid North America. 2004;22(1):27–43 pharmacology. Dev Disabil Res Rev. metabolizer. Paediatr Anaesth. 334. Davidson AJ. Anesthesia and 2010;16(3):233–238 2007;17(7):684–687 neurotoxicity to the developing brain: 313. Pichini S, Papaseit E, Joya X, et al. 324. Kelly LE, Rieder M, van den Anker J, the clinical relevance. Paediatr Pharmacokinetics and therapeutic et al. More codeine fatalities after Anaesth. 2011;21(7):716–721 drug monitoring of psychotropic tonsillectomy in North American 335. Reddy SV. Effect of general anesthetics drugs in pediatrics. Ther Drug Monit. children. Pediatrics. 2012;129(5). on the developing brain. J Anaesthesiol 2009;31(3):283–318 Available at: www.pediatrics. org/ cgi/ Clin Pharmacol. 2012;28(1):6–10 314. Tibussek D, Distelmaier F, Schönberger content/ full/ 129/ 5/ e1343 S, Göbel U, Mayatepek E. Antiepileptic 336. Nemergut ME, Aganga D, Flick RP. 325. Farber JM. Clinical practice guideline: treatment in paediatric oncology— Anesthetic neurotoxicity: what to diagnosis and management an interdisciplinary challenge. Klin tell the parents? Paediatr Anaesth. of childhood obstructive sleep Padiatr. 2006;218(6):340–349 2014;24(1):120–126 apnea syndrome. Pediatrics. 315. Wilkinson GR. Drug metabolism 2002;110(6):1255–1257; author reply: 337. Olsen EA, Brambrink AM. Anesthesia and variability among patients 1255–1257 for the young child undergoing in drug response. N Engl J Med. ambulatory procedures: current 326. Schechter MS; Section on Pediatric 2005;352(21):2211–2221 concerns regarding harm to Pulmonology, Subcommittee on the developing brain. Curr Opin 316. Salem F, Rostami-Hodjegan A, Johnson Obstructive Sleep Apnea Syndrome. Anaesthesiol. 2013;26(6):677–684 TN. Do children have the same Technical report: diagnosis and vulnerability to metabolic drug–drug management of childhood obstructive 338. Green SM, Coté CJ. Ketamine and interactions as adults? A critical sleep apnea syndrome. Pediatrics. neurotoxicity: clinical perspectives and analysis of the literature. J Clin 2002;109(4). Available at: www. implications for emergency medicine. Pharmacol. 2013;53(5):559–566 pediatrics. org/ cgi/ content/ full/ 109/ 4/ Ann Emerg Med. 2009;54(2):181–190 317. Funk RS, Brown JT, Abdel-Rahman e69 339. Brown KA, Laferrière A, Moss IR. SM. Pediatric pharmacokinetics: 327. Marcus CL, Brooks LJ, Draper KA, Recurrent hypoxemia in young human development and drug et al; American Academy of Pediatrics. children with obstructive sleep disposition. Pediatr Clin North Am. Diagnosis and management apnea is associated with reduced 2012;59(5):1001–1016 of childhood obstructive sleep opioid requirement for analgesia. 318. Anderson BJ. My child is unique: the apnea syndrome. Pediatrics. Anesthesiology. 2004;100(4):806–810; pharmacokinetics are universal. 2012;130(3):576–584 discussion: 5A Paediatr Anaesth. 2012;22(6):530–538 328. Coté CJ, Posner KL, Domino KB. 340. Moss IR, Brown KA, Laferrière A. 319. Elie V, de Beaumais T, Fakhoury M, Death or neurologic injury after Recurrent hypoxia in rats during Jacqz-Aigrain E. Pharmacogenetics tonsillectomy in children with a focus development increases subsequent and individualized therapy in on obstructive sleep apnea: Houston, respiratory sensitivity to fentanyl. children: immunosuppressants, we have a problem! Anesth Analg. Anesthesiology. 2006;105(4):715–718 antidepressants, anticancer 2014;118(6):1276–1283 and anti-inﬂ ammatory 341. Litman RS, Kottra JA, Berkowitz drugs. Pharmacogenomics. 329. Wheeler M, Coté CJ. Preoperative RJ, Ward DS. Upper airway 2011;12(6):827–843 pregnancy testing in a tertiary obstruction during midazolam/ 320. Chen ZR, Somogyi AA, Reynolds G, care children’s hospital: a medico- nitrous oxide sedation in children Bochner F. Disposition and metabolism legal conundrum. J Clin Anesth. with enlarged tonsils. Pediatr Dent. of codeine after single and chronic 1999;11(1):56–63 1998;20(5):318–320 doses in one poor and seven extensive 330. Neuman G, Koren G. Safety 342. Fishbaugh DF, Wilson S, Preisch JW, metabolisers. Br J Clin Pharmacol. of procedural sedation in Weaver JM II. Relationship of tonsil size 1991;31(4):381–390 pregnancy. J Obstet Gynaecol Can. on an airway blockage maneuver in 321. Gasche Y, Daali Y, Fathi M, et al. 2013;35(2):168–173 children during sedation. Pediatr Dent. 1997;19(4):277–281 Codeine intoxication associated with 331. Larcher V. Developing guidance ultrarapid CYP2D6 metabolism. N Engl for checking pregnancy status in 343. Heinrich S, Birkholz T, Ihmsen H, J Med. 2004;351(27):2827–2831 adolescent girls before surgical, Irouschek A, Ackermann A, Schmidt J. 322. Kirchheiner J, Schmidt H, Tzvetkov M, radiological or other procedures. Arch Incidence and predictors of difﬁ cult et al. Pharmacokinetics of codeine Dis Child. 2012;97(10):857–860 laryngoscopy in 11, 219 pediatric

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e26 FROM THE AMERICAN ACADEMY OF PEDIATRICS anesthesia procedures. Paediatr you don’t know about. Jt Comm J Qual Pediatrics. 2004;114(1). Available at: Anaesth. 2012;22(8):729–736 Improv. 2001;27(10):522–532 www.pediatrics. org/ cgi/ content/ full/ 114/ 1/ e74 344. Kumar HV, Schroeder JW, Gang Z, 354. May T, Aulisio MP. Medical Sheldon SH. Mallampati score and malpractice, mistake prevention, and 364. Maher EN, Hansen SF, Heine M, Meers pediatric obstructive sleep apnea. J compensation. Kennedy Inst Ethics J. H, Yaster M, Hunt EA. Knowledge Clin Sleep Med. 2014;10(9):985–990 2001;11(2):135–146 of procedural sedation and analgesia of emergency medicine 345. Anderson BJ, Meakin GH. Scaling for 355. Kazandjian VA. When you hear hoofs, think horses, not zebras: an physicians. Pediatr Emerg Care. size: some implications for paediatric 2007;23(12):869–876 anaesthesia dosing. Paediatr Anaesth. evidence-based model of health care 2002;12(3):205–219 accountability. J Eval Clin Pract. 365. Fehr JJ, Boulet JR, Waldrop WB, Snider 2002;8(2):205–213 R, Brockel M, Murray DJ. Simulation- 346. Ramsay MA, Savege TM, Simpson based assessment of pediatric BR, Goodwin R. Controlled sedation 356. Connor M, Ponte PR, Conway J. Multidisciplinary approaches to anesthesia skills. Anesthesiology. with alphaxalone-alphadolone. BMJ. 2011;115(6):1308–1315 1974;2(5920):656–659 reducing error and risk in a patient care setting. Crit Care Nurs Clin North 366. McBride ME, Waldrop WB, Fehr JJ, 347. Agrawal D, Feldman HA, Krauss Am. 2002;14(4):359–367, viii Boulet JR, Murray DJ. Simulation in B, Waltzman ML. Bispectral index pediatrics: the reliability and validity monitoring quantifi es depth 357. Gosbee J. Human factors engineering and patient safety. Qual Saf Health of a multiscenario assessment. of sedation during emergency Pediatrics. 2011;128(2):335–343 department procedural sedation and Care. 2002;11(4):352–354 analgesia in children. Ann Emerg Med. 358. Tuong B, Shnitzer Z, Pehora C, et al. 367. Fehr JJ, Honkanen A, Murray DJ. 2004;43(2):247–255 The experience of conducting Mortality Simulation in pediatric anesthesiology. Paediatr Anaesth. 2012;22(10):988–994 348. Cravero JP, Blike GT, Surgenor and Morbidity reviews in a pediatric SD, Jensen J. Development and interventional radiology service: a 368. Martinez MJ, Siegelman L. The validation of the Dartmouth Operative retrospective study. J Vasc Interv new era of pretracheal/precordial Conditions Scale. Anesth Analg. Radiol. 2009;20(1):77–86 stethoscopes. Pediatr Dent. 2005;100(6):1614–1621 359. Tjia I, Rampersad S, Varughese A, 1999;21(7):455–457 349. Mayers DJ, Hindmarsh KW, Sankaran K, et al. Wake Up Safe and root cause 369. Biro P. Electrically amplifi ed Gorecki DK, Kasian GF. Chloral hydrate analysis: quality improvement in precordial stethoscope. J Clin Monit. disposition following single-dose pediatric anesthesia. Anesth Analg. 1994;10(6):410–412 2014;119(1):122–136 administration to critically ill neonates 370. Philip JH, Raemer DB. An electronic and children. Dev Pharmacol Ther. 360. Bhatt M, Kennedy RM, Osmond MH, stethoscope is judged better than 1991;16(2):71–77 et al; Consensus Panel on Sedation conventional stethoscopes for 350. Terndrup TE, Dire DJ, Madden CM, Research of Pediatric Emergency anesthesia monitoring. J Clin Monit. Davis H, Cantor RM, Gavula DP. A Research Canada (PERC);Pediatric 1986;2(3):151–154 prospective analysis of intramuscular Emergency Care Applied Research 371. Hochberg MG, Mahoney WK. Monitoring meperidine, promethazine, and Network (PECARN). Consensus-based of respiration using an amplifi ed chlorpromazine in pediatric recommendations for standardizing pretracheal stethoscope. J Oral emergency department patients. Ann terminology and reporting adverse Maxillofac Surg. 1999;57(7):875–876 Emerg Med. 1991;20(1):31–35 events for emergency department procedural sedation and analgesia 372. Fredette ME, Lightdale JR. Endoscopic 351. Macnab AJ, Levine M, Glick N, Susak in children. Ann Emerg Med. sedation in pediatric practice. L, Baker-Brown G. A research tool 2009;53(4):426–435.e4 Gastrointest Endosc Clin N Am. for measurement of recovery from 2008;18(4):739–751, ix sedation: the Vancouver Sedative 361. Barker SJ, Hyatt J, Shah NK, Kao YJ. 373. Deitch K, Chudnofsky CR, Dominici P. Recovery Scale. J Pediatr Surg. The effect of sensor malpositioning The utility of supplemental oxygen 1991;26(11):1263–1267 on pulse oximeter accuracy during hypoxemia. Anesthesiology. during emergency department 352. Chernik DA, Gillings D, Laine H, 1993;79(2):248–254 procedural sedation and analgesia et al. Validity and reliability of the with midazolam and fentanyl: a Observer’s Assessment of Alertness/ 362. Kelleher JF, Ruff RH. The penumbra randomized, controlled trial. Ann Sedation Scale: study with intravenous effect: vasomotion-dependent Emerg Med. 2007;49(1):1–8 midazolam. J Clin Psychopharmacol. pulse oximeter artifact due to 374. Burton JH, Harrah JD, Germann CA, 1990;10(4):244–251 probe malposition. Anesthesiology. Dillon DC. Does end-tidal carbon 1989;71(5):787–791 353. Bagian JP, Lee C, Gosbee J, et al. dioxide monitoring detect respiratory Developing and deploying a patient 363. Reeves ST, Havidich JE, Tobin DP. events prior to current sedation safety program in a large health care Conscious sedation of children with monitoring practices? Acad Emerg delivery system: you can’t fi x what propofol is anything but conscious. Med. 2006;13(5):500–504

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e27 375. Wilson S, Farrell K, Griffen A, Coury 388. Fitzmaurice LS, Wasserman GS, Knapp HCl and lidocaine HCl in pediatric D. Conscious sedation experiences in JF, Roberts DK, Waeckerle JF, Fox M. dental patients. Pediatr Dent. graduate pediatric dentistry programs. TAC use and absorption of cocaine in a 2000;22(4):307–311 Pediatr Dent. 2001;23(4):307–314 pediatric emergency department. Ann 401. American Academy of Pediatric Emerg Med. 1990;19(5):515–518 376. Allegaert K, van den Anker JN. Clinical Dentistry, Council on Clinical Affairs. pharmacology in neonates: small 389. Tipton GA, DeWitt GW, Eisenstein SJ. Guidelines on use of local anesthesia size, huge variability. Neonatology. Topical TAC (tetracaine, adrenaline, for pediatric dental patients. Chicago, 2014;105(4):344–349 cocaine) solution for local anesthesia IL: American Academy of Pediatric 377. Coté CJ, Zaslavsky A, Downes JJ, in children: prescribing inconsistency Dentistry; 2015. Available at: http:// et al. Postoperative apnea in former and acute toxicity. South Med J. www.aapd. org/ media/ policies_ preterm infants after inguinal 1989;82(11):1344–1346 guidelines/ g_ localanesthesia. pdf. herniorrhaphy: a combined analysis. 390. Gunter JB. Beneﬁ t and risks of local Accessed May 27, 2016 Anesthesiology. 1995;82(4):809–822 anesthetics in infants and children. 402. Ludot H, Tharin JY, Belouadah M, 378. Havidich JE, Beach M, Dierdorf SF, Paediatr Drugs. 2002;4(10):649–672 Mazoit JX, Malinovsky JM. Successful Onega T, Suresh G, Cravero JP. Preterm 391. Resar LM, Helfaer MA. Recurrent resuscitation after ropivacaine versus term children: analysis of seizures in a neonate after lidocaine and lidocaine-induced ventricular sedation/anesthesia adverse events administration. J Perinatol. arrhythmia following posterior lumbar and longitudinal risk. Pediatrics. 1998;18(3):193–195 plexus block in a child. Anesth Analg. 2016;137(3):1–9 2008;106(5):1572–1574 392. Yagiela JA. Local anesthetics. In: 379. Nasr VG, Davis JM. Anesthetic use Yagiela JA, Dowd FJ, Johnson 403. Eren CS, Tasyurek T, Guneysel O. in newborn infants: the urgent need BS, Mariotti AJ, Neidle EA, eds. Intralipid emulsion treatment for rigorous evaluation. Pediatr Res. Pharmacology and Therapeutics for as an antidote in lipophilic drug 2015;78(1):2–6 Dentistry. 6th ed. St. Louis, MO: Mosby, intoxications: a case series. Am J Emerg Med. 2014;32(9):1103–1108 380. Sinner B, Becke K, Engelhard K. General Elsevier; 2011:246–265 anaesthetics and the developing 393. Haas DA. An update on local 404. Evans JA, Wallis SC, Dulhunty JM, Pang brain: an overview. Anaesthesia. anesthetics in dentistry. J Can Dent G. Binding of local anaesthetics to the 2014;69(9):1009–1022 Assoc. 2002;68(9):546–551 lipid emulsion Clinoleic™ 20%. Anaesth Intensive Care. 2013;41(5):618–622 381. Yu CK, Yuen VM, Wong GT, Irwin MG. 394. Malamed SF. Anesthetic considerations The effects of anaesthesia on the in dental specialties. In: Malamed SF, 405. Presley JD, Chyka PA. Intravenous developing brain: a summary of the ed. Handbook of Local Anesthesia. lipid emulsion to reverse acute drug clinical evidence. F1000 Res. 2013;2:166 6th ed. St. Louis, MO: Elsevier; toxicity in pediatric patients. Ann 382. Davidson A, Flick RP. 2013:277–291 Pharmacother. 2013;47(5):735–743 Neurodevelopmental implications of 395. Malamed SF. The needle. In: Malamed 406. Li Z, Xia Y, Dong X, et al. Lipid the use of sedation and analgesia SF, ed. Handbook of Local Anesthetics. resuscitation of bupivacaine toxicity: in neonates. Clin Perinatol. 6th ed. St Louis, MO: Elsevier; long-chain triglyceride emulsion 2013;40(3):559–573 2013:92–100 provides beneﬁ ts over long- and 383. Lönnqvist PA. Toxicity of local 396. Malamed SF. Pharmacology of local medium-chain triglyceride emulsion. anesthetic drugs: a pediatric anesthetics. In: Malamed SF, ed. Anesthesiology. 2011;115(6):1219–1228 perspective. Paediatr Anaesth. Handbook of Local Anesthesia. 6th ed. 407. Maher AJ, Metcalfe SA, Parr S. 2012;22(1):39–43 St. Louis, MO: Elsevier; 2013:25–38 Local anaesthetic toxicity. Foot. 384. Wahl MJ, Brown RS. Dentistry’s 397. Ram D, Amir E. Comparison of articaine 2008;18(4):192–197 wonder drugs: local anesthetics 4% and lidocaine 2% in paediatric 408. Corman SL, Skledar SJ. Use of lipid and vasoconstrictors. Gen Dent. dental patients. Int J Paediatr Dent. emulsion to reverse local anesthetic- 2010;58(2):114–123; quiz: 124–125 2006;16(4):252–256 induced toxicity. Ann Pharmacother. 385. Bernards CM, Hadzic A, Suresh S, 398. Jakobs W, Ladwig B, Cichon P, Ortel 2007;41(11):1873–1877 Neal JM. Regional anesthesia in R, Kirch W. Serum levels of articaine 409. Litz RJ, Popp M, Stehr SN, Koch anesthetized or heavily sedated 2% and 4% in children. Anesth Prog. T. Successful resuscitation of a patients. Reg Anesth Pain Med. 1995;42(3–4):113–115 patient with ropivacaine-induced 2008;33(5):449–460 399. Wright GZ, Weinberger SJ, Friedman asystole after axillary plexus block 386. Ecoffey C. Pediatric regional CS, Plotzke OB. Use of articaine local using lipid infusion. Anaesthesia. anesthesia—update. Curr Opin anesthesia in children under 4 years 2006;61(8):800–801 Anaesthesiol. 2007;20(3):232–235 of age—a retrospective report. Anesth 410. Raso SM, Fernandez JB, Beobide EA, 387. Aubuchon RW. Sedation liabilities Prog. 1989;36(6):268–271 Landaluce AF. Methemoglobinemia and in pedodontics. Pediatr Dent. 400. Malamed SF, Gagnon S, Leblanc D. CNS toxicity after topical application 1982;4:171–180 A comparison between articaine of EMLA to a 4-year-old girl with

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e28 FROM THE AMERICAN ACADEMY OF PEDIATRICS molluscum contagiosum. Pediatr 423. Roelofse J. Conscious sedation: making sedation in children. Anesth Analg. Dermatol. 2006;23(6):592–593 our treatment options safe and sound. 2006;102(2):383–388 SADJ. 2000;55(5):273–276 411. Larson A, Stidham T, Banerji 434. Messieha ZS, Ananda RC, Hoffman WE, S, Kaufman J. Seizures and 424. Wilson S, Creedon RL, George M, Punwani IC, Koenig HM. Bispectral methemoglobinemia in an infant after Troutman K. A history of sedation Index System (BIS) monitoring excessive EMLA application. Pediatr guidelines: where we are headed reduces time to discharge in children Emerg Care. 2013;29(3):377–379 in the future. Pediatr Dent. requiring intramuscular sedation 1996;18(3):194–199 and general anesthesia for outpatient 412. Tran AN, Koo JY. Risk of systemic dental rehabilitation. Pediatr Dent. 425. Miner JR, Heegaard W, Plummer D. toxicity with topical lidocaine/ 2004;26(3):256–260 prilocaine: a review. J Drugs Dermatol. End-tidal carbon dioxide monitoring 2014;13(9):1118–1122 during procedural sedation. Acad 435. McDermott NB, VanSickle T, Motas D, Emerg Med. 2002;9(4):275–280 Friesen RH. Validation of the bispectral 413. Young KD. Topical anaesthetics: what’s index monitor during conscious and 426. Vascello LA, Bowe EA. A case for new? Arch Dis Child Educ Pract Ed. deep sedation in children. Anesth capnographic monitoring as a 2015;100(2):105–110 Analg. 2003;97(1):39–43 standard of care. J Oral Maxillofac 414. Gaufberg SV, Walta MJ, Workman Surg. 1999;57(11):1342–1347 436. Schmidt AR, Weiss M, Engelhardt T. The TP. Expanding the use of topical paediatric airway: basic principles 427. Coté CJ, Wax DF, Jennings MA, Gorski anesthesia in wound management: and current developments. Eur J CL, Kurczak-Klippstein K. Endtidal sequential layered application of Anaesthesiol. 2014;31(6):293–299 carbon dioxide monitoring in children topical lidocaine with epinephrine. Am with congenital heart disease during 437. Nagler J, Bachur RG. Advanced airway J Emerg Med. 2007;25(4):379–384 sedation for cardiac catheterization management. Curr Opin Pediatr. 415. Eidelman A, Weiss JM, Baldwin CL, by nonanesthesiologists. Paediatr 2009;21(3):299–305 Enu IK, McNicol ED, Carr DB. Topical Anaesth. 2007;17(7):661–666 438. Berry AM, Brimacombe JR, Verghese anaesthetics for repair of dermal 428. Bowdle TA. Depth of anesthesia C. The laryngeal mask airway in laceration. Cochrane Database Syst monitoring. Anesthesiol Clin. emergency medicine, neonatal Rev. 2011;6:CD005364 2006;24(4):793–822 resuscitation, and intensive care 416. Next-generation pulse oximetry. Health medicine. Int Anesthesiol Clin. 429. Rodriguez RA, Hall LE, Duggan S, 1998;36(2):91–109 Devices. 2003;32(2):49–103 Splinter WM. The bispectral index 417. Barker SJ. “Motion-resistant” does not correlate with clinical 439. Patterson MD. Resuscitation update for pulse oximetry: a comparison of signs of inhalational anesthesia the pediatrician. Pediatr Clin North Am. new and old models. Anesth Analg. during sevofl urane induction and 1999;46(6):1285–1303 2002;95(4):967–972 arousal in children. Can J Anaesth. 440. Diggs LA, Yusuf JE, De Leo G. An update 2004;51(5):472–480 on out-of-hospital airway management 418. Malviya S, Reynolds PI, Voepel-Lewis T, practices in the United States. et al. False alarms and sensitivity of 430. Overly FL, Wright RO, Connor FA Jr, Resuscitation. 2014;85(7):885–892 conventional pulse oximetry versus the Fontaine B, Jay G, Linakis JG. Bispectral Masimo SET technology in the pediatric analysis during pediatric procedural 441. Wang HE, Mann NC, Mears G, Jacobson postanesthesia care unit. Anesth sedation. Pediatr Emerg Care. K, Yealy DM. Out-of-hospital airway Analg. 2000;90(6):1336–1340 2005;21(1):6–11 management in the United States. Resuscitation. 2011;82(4):378–385 419. Barker SJ, Shah NK. Effects of motion 431. Mason KP, O’Mahony E, Zurakowski on the performance of pulse oximeters D, Libenson MH. Effects of 442. Ritter SC, Guyette FX. Prehospital in volunteers. Anesthesiology. dexmedetomidine sedation on the pediatric King LT-D use: a pilot 1996;85(4):774–781 EEG in children. Paediatr Anaesth. study. Prehosp Emerg Care. 2011;15(3):401–404 420. Barker SJ, Shah NK. The effects of 2009;19(12):1175–1183 443. Selim M, Mowafi H, Al-Ghamdi motion on the performance of pulse 432. Malviya S, Voepel-Lewis T, Tait AR, A, Adu-Gyamfi Y. Intubation via oximeters in volunteers (revised Watcha MF, Sadhasivam S, Friesen LMA in pediatric patients with publication). Anesthesiology. RH. Effect of age and sedative agent diffi cult airways. Can J Anaesth. 1997;86(1):101–108 on the accuracy of bispectral index in 1999;46(9):891–893 421. Colman Y, Krauss B. Microstream detecting depth of sedation in children. capnograpy technology: a new Pediatrics. 2007;120(3). Available at: 444. Munro HM, Butler PJ, Washington EJ. approach to an old problem. J Clin www.pediatrics. org/ cgi/ content/ full/ Freeman-Sheldon (whistling face) Monit Comput. 1999;15(6):403–409 120/ 3/ e461 syndrome: anaesthetic and airway management. Paediatr Anaesth. 422. Wright SW. Conscious sedation in the 433. Sadhasivam S, Ganesh A, Robison 1997;7(4):345–348 emergency department: the value of A, Kaye R, Watcha MF. Validation capnography and pulse oximetry. Ann of the bispectral index monitor 445. Horton MA, Beamer C. Powered Emerg Med. 1992;21(5):551–555 for measuring the depth of intraosseous insertion provides safe

Downloaded from www.aappublications.org/news by guest on October 25, 2018 PEDIATRICS Volume 138 , number 1 , July 2016 e29 and effective vascular access for factors approach aimed at improving 467. Frampton A, Browne GJ, Lam pediatric emergency patients. Pediatr the effi cacy and safety of sedation/ LT, Cooper MG, Lane LG. Nurse Emerg Care. 2008;24(6):347–350 analgesia care. Qual Manag Health administered relative analgesia using 446. Gazin N, Auger H, Jabre P, et al. Care. 2001;10(1):17–36 high concentration nitrous oxide to facilitate minor procedures in children Effi cacy and safety of the EZ-IO™ 456. Reiter DA, Strother CG, Weingart in an emergency department. Emerg intraosseous device: out-of-hospital SD. The quality of cardiopulmonary Med J. 2003;20(5):410–413 implementation of a management resuscitation using supraglottic algorithm for diffi cult vascular access. airways and intraosseous devices: 468. Everitt I, Younge P, Barnett P. Paediatric Resuscitation. 2011;82(1):126–129 a simulation trial. Resuscitation. sedation in emergency department: what is our practice? Emerg Med 447. Frascone RJ, Jensen J, Wewerka SS, 2013;84(1):93–97 (Fremantle). 2002;14(1):62–66 Salzman JG. Use of the pediatric EZ-IO 457. Schulte-Uentrop L, Goepfert MS. needle by emergency medical services Anaesthesia or sedation for MRI in 469. Krauss B. Continuous-fl ow nitrous providers. Pediatr Emerg Care. children. Curr Opin Anaesthesiol. oxide: searching for the ideal 2009;25(5):329–332 2010;23(4):513–517 procedural anxiolytic for toddlers. Ann Emerg Med. 2001;37(1):61–62 448. Neuhaus D. Intraosseous infusion 458. Schmidt MH, Downie J. Safety fi rst: in elective and emergency pediatric recognizing and managing the risks 470. Otley CC, Nguyen TH. Conscious anesthesia: when should we to child participants in magnetic sedation of pediatric patients with use it? Curr Opin Anaesthesiol. resonance imaging research. Account combination oral benzodiazepines and 2014;27(3):282–287 Res. 2009;16(3):153–173 inhaled nitrous oxide. Dermatol Surg. 2000;26(11):1041–1044 449. Oksan D, Ayfer K. Powered 459. Chavhan GB, Babyn PS, Singh M, intraosseous device (EZ-IO) for Vidarsson L, Shroff M. MR imaging at 471. Luhmann JD, Kennedy RM, Jaffe critically ill patients. Indian Pediatr. 3.0 T in children: technical differences, DM, McAllister JD. Continuous-fl ow 2013;50(7):689–691 safety issues, and initial experience. delivery of nitrous oxide and oxygen: Radiographics. 2009;29(5):1451–1466 a safe and cost-effective technique for 450. Santos D, Carron PN, Yersin B, 460. Kanal E, Shellock FG, Talagala L. inhalation analgesia and sedation of Pasquier M. EZ-IO(®) intraosseous Safety considerations in MR imaging. pediatric patients. Pediatr Emerg Care. device implementation in a pre- Radiology. 1990;176(3):593–606 1999;15(6):388–392 hospital emergency service: a 472. Burton JH, Auble TE, Fuchs SM. prospective study and review 461. Shellock FG, Kanal E. Burns associated Effectiveness of 50% nitrous of the literature. Resuscitation. with the use of monitoring equipment oxide/50% oxygen during laceration 2013;84(4):440–445 during MR procedures. J Magn Reson Imaging. 1996;6(1):271–272 repair in children. Acad Emerg Med. 451. Tan GM. A medical crisis management 1998;5(2):112–117 462. Shellock FG. Magnetic resonance simulation activity for pediatric dental safety update 2002: implants and 473. Gregory PR, Sullivan JA. Nitrous oxide residents and assistants. J Dent Educ. devices. J Magn Reson Imaging. compared with intravenous regional 2011;75(6):782–790 2002;16(5):485–496 anesthesia in pediatric forearm 452. Schinasi DA, Nadel FM, Hales 463. Dempsey MF, Condon B, Hadley DM. MRI fracture manipulation. J Pediatr R, Boswinkel JP, Donoghue AJ. safety review. Semin Ultrasound CT Orthop. 1996;16(2):187–191 Assessing pediatric residents’ MR. 2002;23(5):392–401 474. Hennrikus WL, Shin AY, Klingelberger clinical performance in procedural CE. Self-administered nitrous oxide sedation: a simulation-based needs 464. Department of Health and Human Services, Centers for Disease and a hematoma block for analgesia in assessment. Pediatr Emerg Care. the outpatient reduction of fractures 2013;29(4):447–452 Control and PreventionCriteria for a Recommended Standard: Waste in children. J Bone Joint Surg Am. 453. Rowe R, Cohen RA. An evaluation of a Anesthetic Gases: Occupational 1995;77(3):335–339 virtual reality airway simulator. Anesth Hazards in Hospitals. 2007. Publication 475. Hennrikus WL, Simpson RB, Analg. 2002;95(1):62–66 2007-151. Available at: http:// www. cdc. Klingelberger CE, Reis MT. Self- 454. Medina LS, Racadio JM, Schwid gov/ niosh/ docs/ 2007- 151/ pdfs/ 2007- administered nitrous oxide analgesia HA. Computers in radiology—the 151. pdf. Accessed May 27, 2016 for pediatric fracture reductions. J sedation, analgesia, and contrast 465. O’Sullivan I, Benger J. Nitrous oxide in Pediatr Orthop. 1994;14(4):538–542 media computerized simulator: emergency medicine. Emerg Med J. 476. Wattenmaker I, Kasser JR, McGravey a new approach to train and 2003;20(3):214–217 A. Self-administered nitrous oxide for evaluate radiologists’ responses to 466. Kennedy RM, Luhmann JD, Luhmann SJ. fracture reduction in children in an critical incidents. Pediatr Radiol. Emergency department management emergency room setting. J Orthop 2000;30(5):299–305 of pain and anxiety related to Trauma. 1990;4(1):35–38 455. Blike G, Cravero J, Nelson E. Same orthopedic fracture care: a guide to 477. Gamis AS, Knapp JF, Glenski JA. patients, same critical events— analgesic techniques and procedural Nitrous oxide analgesia in a pediatric different systems of care, different sedation in children. Paediatr Drugs. emergency department. Ann Emerg outcomes: description of a human 2004;6(1):11–31 Med. 1989;18(2):177–181

Downloaded from www.aappublications.org/news by guest on October 25, 2018 e30 FROM THE AMERICAN ACADEMY OF PEDIATRICS 478. Kalach N, Barbier C, el Kohen R, 485. Houpt MI, Limb R, Livingston RL. Clinical laceration repair in children. Pediatr et al. Tolerance of nitrous oxide-oxygen effects of nitrous oxide conscious Emerg Care. 2012;28(12):1297–1301 sedation for painful procedures sedation in children. Pediatr Dent. 492. Seith RW, Theophilos T, Babl FE. in emergency pediatrics: report of 2004;26(1):29–36 Intranasal fentanyl and high- 600 cases [in French]. Arch Pediatr. 486. Shapira J, Holan G, Guelmann M, concentration inhaled nitrous 2002;9(11):1213–1215 Cahan S. Evaluation of the effect oxide for procedural sedation: a 479. Michaud L, Gottrand F, Ganga-Zandzou of nitrous oxide and hydroxyzine prospective observational pilot PS, et al. Nitrous oxide sedation in controlling the behavior of the study of adverse events and depth in pediatric patients undergoing pediatric dental patient. Pediatr Dent. of sedation. Acad Emerg Med. gastrointestinal endoscopy. J Pediatr 1992;14(3):167–170 2012;19(1):31–36 Gastroenterol Nutr. 1999;28(3):310–314 487. Primosch RE, Buzzi IM, Jerrell G. Effect 493. Klein U, Robinson TJ, Allshouse A. End- 480. Baskett PJ. Analgesia for the dressing of nitrous oxide-oxygen inhalation expired nitrous oxide concentrations of burns in children: a method using with scavenging on behavioral and compared to ﬂ owmeter settings neuroleptanalgesia and Entonox. physiological parameters during during operative dental treatment Postgrad Med J. 1972;48(557):138–142 routine pediatric dental treatment. in children. Pediatr Dent. 481. Veerkamp JS, van Amerongen WE, Pediatr Dent. 1999;21(7):417–420 2011;33(1):56–62 Hoogstraten J, Groen HJ. Dental 488. McCann W, Wilson S, Larsen P, Stehle 494. Litman RS, Kottra JA, Berkowitz RJ, treatment of fearful children, using B. The effects of nitrous oxide on Ward DS. Breathing patterns and levels nitrous oxide. Part I: treatment times. behavior and physiological parameters of consciousness in children during ASDC J Dent Child. 1991;58(6):453–457 during conscious sedation with a administration of nitrous oxide after 482. Veerkamp JS, Gruythuysen RJ, van moderate dose of chloral hydrate oral midazolam premedication. J Oral Amerongen WE, Hoogstraten J. Dental and hydroxyzine. Pediatr Dent. Maxillofac Surg. 1997;55(12):1372– treatment of fearful children using 1996;18(1):35–41 1377; discussion: 1378–1379 nitrous oxide. Part 2: the parent’s 489. Wilson S, Matusak A, Casamassimo 495. Litman RS, Kottra JA, Verga KA, point of view. ASDC J Dent Child. PS, Larsen P. The effects of nitrous Berkowitz RJ, Ward DS. Chloral 1992;59(2):115–119 oxide on pediatric dental patients hydrate sedation: the additive sedative 483. Veerkamp JS, Gruythuysen RJ, van sedated with chloral hydrate and respiratory depressant effects Amerongen WE, Hoogstraten J. Dental and hydroxyzine. Pediatr Dent. of nitrous oxide. Anesth Analg. treatment of fearful children using 1998;20(4):253–258 1998;86(4):724–728 nitrous oxide. Part 3: anxiety during 490. Pedersen RS, Bayat A, Steen NP, 496. American Academy of Pediatric sequential visits. ASDC J Dent Child. Jacobsson ML. Nitrous oxide provides Dentistry, Council on Clinical Affairs. 1993;60(3):175–182 safe and effective analgesia for minor Guideline on use of nitrous oxide for 484. Veerkamp JS, Gruythuysen RJ, paediatric procedures—a systematic pediatric dental patients. Chicago, Hoogstraten J, van Amerongen WE. review [abstract]. Dan Med J. IL: American Academy of Pediatric Dental treatment of fearful children 2013;60(6):A4627 Dentistry; 2013. Available at: http:// using nitrous oxide. Part 4: anxiety 491. Lee JH, Kim K, Kim TY, et al. A www.aapd. org/ media/ policies_ after two years. ASDC J Dent Child. randomized comparison of nitrous guidelines/ g_ nitrous. pdf. Accessed 1993;60(4):372–376 oxide versus intravenous ketamine for May 27, 2016

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