COMMENTARIES

Editorials represent the opinions of the authors and not necessarily those of the American Dental Association.

COMMENTARY New and general guidelines Why the changes?

Editor’s note: In Dionne’s commentary (“Raise the Bar for Safe Sedation, Jason H. Goodchild, DMD; Mark ” 133 Donaldson, BSP, ACPR, PharmD, Not Barriers for Access to Care, on page ) and in this commentary, the FACHE authors discuss the latest guidelines for using and teaching sedation and general anesthesia by dentists. Although the authors of both commentaries approach the subject of sedation and general anesthesia from different points of view, their main arguments focus on the concern for patient safety. Hope- fully, providing both of these perspectives will afford JADA readers a better and more comprehensive understanding of the very serious issues involved and the challenges ahead. uring the October 2016 American Dental Association (ADA) annual meeting, the House of Delegates voted to approve D Resolution 37 and update guidelines for the teaching and use of sedation and general anesthesia by oral health care professionals 1 2 (OHCPs). , The changes to these documents primarily update educational requirements and clinical guidelines for the use of minimal and moderate sedation. First developed in 1971, this update to the ADA’s sedation and general anesthesia guidelines is the latest evolution of a document that has been revised 10 times (most recently in 2012) and further attempts to bring 3 clarity and direction for OHCPs wishing to use these modalities. WHAT ARE THE MAJOR CHANGES? Minimal sedation. For minimal sedation via the enteral route, the dosing of is now limited to a single dose or multiple doses in which the cumulative amount does not exceed the US Food and Drug Administration’s (FDA) maximum recommended dose (MRD) for unmonitored home use. Supplemental dosing, as described in 2012 in which the total aggregate dose must not exceed 1.5 times the MRD on the day of treatment, is now pro- hibited and replaced by statements indicating that if cumulative doses exceed the MRD, or if multiple enteral are used, that guidelines for moderate sedation must apply. The revisions, including the use of the MRD as a limit, are meant to “guide dosing for minimal sedation” and are 1 “intended to create [a] margin of safety.” Also, for minimal sedation, the use of and oxygen analgesia, specifically permitted by the 2012 guidelines when used in combination with a single enteral drug, has changed. Although still allowed, the original language is replaced by a statement advising that nitrous oxide and oxygen analgesia when

138 JADA 148(3) http://jada.ada.org March 2017 COMMENTARIES used in combination with a guidelines is to improve procedural WHAT MAKES OUR PATIENTS SO 3 agent may produce minimal, moder- safety and efficacy. These guidelines CHALLENGING? ate, deep sedation, or general are then disseminated to the state Epidemiologic data continue to anesthesia. boards and can be incorporated into demonstrate that we are an aging 21 Moderate sedation. For moder- regulations to help fulfill the population. The authors of this ate sedation, the educational re- mandate of every dental board: to same report further predict that the quirements have been revised to protect the public. Tragic outcomes United States’s 65-and-over popu- recommend a didactic course con- after dental sedation procedures lation is projected to nearly double sisting of 60 hours of instruction and continue to occur, and these out- over the next 3 decades, from 48 administration of sedation to at least comes can prompt scrutiny of million to 88 million by 2050. 20 individually managed patients guidelines and regulations, and ulti- Moreover, this older population is with no distinction made as to the mately necessitate changes and up- 5 11 retaining their dentition and route of medication administration. dates. - It is therefore essential that requiring the expertise of OHCPs In other words, in 2012 moderate documents outlining education and much later in life than has been 22 24 enteral sedation course duration was best practices stay up-to-date and experienced in the past. - Unfor- separate and different from paren- reflect not only the evolution of tunately, although people are living teral, but the 2016 revision outlines medications and monitoring, but longer, that does not necessarily training and clinical guidelines based also incorporate knowledge gained 12 18 mean that they are living healthier. on intended level of sedation, not after review of adverse events. - Early studies had estimated that 30% route of medication administration. In addition, previous guidelines of patients visiting a dental office Moderate sedation, deep do not and cannot continuously suffer from at least 1 medical condi- 25 26 sedation, and general anesthesia. In account for the 1 variable that is tion. , The Centers for Disease addition, for moderate sedation, always changing—our patients. In Control and Prevention has reported deep sedation, and general anes- the last 4 years and beyond, the that, “As of 2012, about half of all thesia, the monitoring of ventilation most important changes clinical adults—117 million people—had 1 or more chronic health conditions. And Previous guidelines do not and cannot 1 of 4 adults had 2 or more chronic ”27 continuously account for the 1 variable that is health conditions. Further complicating the medical status of always changing—our patients. patients is that polypharmacology is must now be assisted by capnog- OHCPs have faced include becoming the norm as patients get raphy and monitoring of end-tidal providing safe and effective seda- into their sixth, seventh, and eighth carbon dioxide (CO2). In the previ- tion and anesthesia services to a decades of life, requiring more ous document, end-tidal CO2 moni- population that is older, sicker, medications to treat their different 28 29 toring was only required for and taking more medications (both concurrent chronic diseases. , It is intubated patients and was only licit and illicit). Poor patient selec- therefore essential that OHCPs un- suggested for nonintubated patients. tion, even coupled with properly dertake a comprehensive review of Finally, patient evaluation for these 3 educated OHCPs, safe drugs, and every patient’s medical as well as deepest levels of sedation and anes- up-to-date monitoring equipment, pharmacologic history before any thesia should include body mass in- can still result in unintended and 5 11 procedure. dex and the consideration of patients catastrophic outcomes. - This written and verbal review with obstructive sleep as part In medical practice, there is the needs to include an emphasis on of the preoperative risk assessment. common idiom of “matching the bothlicitandillicitmedicationuse Pediatric sedation. Pediatric right drug, at the right dose and as well as any complementary and sedation is now covered by the 2016 the right time, for the right patient alternative medications. Among 19 20 update detailed in the “Guidelines and the right procedure.” - The adults 65 yearsorolder,40%take5 to 9 medications regularly and 18% for Monitoring and Management ADA has historically enhanced this 30 32 on Pediatric Patients Before, During, approach by further considering the take 10 or more medications. - and After Sedation for Diagnostic right setting, the right education, and Furthermore, considering that and Therapeutic Procedures: Update even the right equipment. Regard- nearly 70%ofthesepeopledonot 4 2016.” less, with all the excellent intentions discuss their computer-aided and iterations of the guidelines for manufacturing use with their pri- WHY ARE THESE CHANGES the teaching and use of sedation and mary care providers, OHCPs should NEEDED? general anesthesia by OHCPs, pick- ask all patients about their medica- The intent of the ADA’s revised ing the right patients can still be our tion use, particularly when pre- sedation and general anesthesia Achilles’ heel. scribing medications and when

JADA 148(3) http://jada.ada.org March 2017 139 COMMENTARIES

15,45-48 considering the patients’ overall end, capnography and end-tidal CO2 patients. Although the avail- 33 sedative or plan. monitoring should add additional able research is insufficient to clearly Finally, older adults are 7 times safety for moderate sedation. delineate the appropriateness of the more likely than younger adults to MRD for minimal sedation, it should experience adverse drug events that USING THE MAXIMUM be considered suitable for 2 impor- require hospitalization, under- RECOMMENDED DOSE FOR tant reasons. First, for OHCPs with scoring the importance for all pre- MINIMAL SEDATION? the smallest amount of sedation scribers to carefully consider In most cases in which minimal or training, it creates a definitive potential drug interactions and use moderate sedation techniques are maximum dose that when patient available resources to mitigate risk used, the use of as factors and potential drug inter- (for example, Lexicomp, Micro- first-line medications continues to be actions are accounted for, should 34 medex, Clinical Pharmacology). recommended given their long his- provide a reasonable safety margin. 38 39 Evaluating the medical stability tory of efficacy and safety. , From Second, because drug effect and and appropriateness for sedation a historical perspective, it is impor- psychomotor impairment do not and anesthesia services for patients tant to understand that the term cease at the conclusion of dental as described above may create a maximum recommended dose is treatment but wane over time, the confusing milieu of disease states, established as a part of the FDA MRD as an intended maximum dose medications, and potential drug approval process onto the for unmonitored home use can interactions. In these situations, the US Pharmacopeia. It serves as a create additional safety for patients OHCP must consider several fac- maximum dose, either given singly who have been dismissed and are no tors: the preoperative fitness of the or as a cumulative amount for un- longer directly supervised by the patient together with the planned monitored home use, and continues dental team. sedative or anesthesia protocol, the to be part of the sedation and anes- setting where treatment will be thesia guidelines. Although not NO MORE DIFFERENTIATION performed, the availability of expressly noted, the mention of BETWEEN ENTERAL AND monitoring equipment, the poten- MRD in the minimal sedation PARENTERAL MODERATE tial for adverse events, and the guidelines relates primarily to tri- SEDATION? ability to rescue the patient should azolam. When was The other significant change with the 35 an adverse event occur. It is not approved in 1982, the indication was approval of Resolution 37 relates enough to simply select inherently for the treatment of short-term specifically to moderate sedation safe medications and expect a wide (it has never received where the route of administration is therapeutic margin to mitigate formal approval by the FDA for the no longer a differentiating factor. procedural risk. The ADA has indication of procedural sedation in Although the of addressed this in the revised clinical dentistry). For the indication of medications is inherently the safest guidelines by stressing the evalua- insomnia and through subsequent route given the first-pass effect, tion of preoperative medical status, FDA reviews, the MRD was estab- enterohepatic circulation, and even 40 41 including implementation of the lished at 0.5 milligrams. , How the presence of the P-glycoprotein American Society of Anesthesiolo- then should an MRD established for pump throughout the intestinal 36 gists Physical Status Classification, insomnia be interpreted to serve as epithelium, it does have its limita- and consideration of the patient’s the maximum dose for minimal tions in regard to predictability both body mass index and the other dental sedation? The FDA’s Web site in onset of effect and profundity of airway-associated risk factors such indicates that per dose maximums response. Drug latency allows for as obstructive . for and are blunted responses, which may give 42 43 Because the definition of both 10 mg and 2 mg, respectively. , the OHCP time to recognize and minimal and moderate sedation in- The equivalent dose of triazolam to manage adverse outcomes, but volves a patient who can maintain a 10 mg diazepam and 2 mg lorazepam interpatient variability still makes patent airway without assistance, is 0.5 mg, which may provide some predictability of response a chal- consideration of airway-associated empiric guidance and predict an lenge. The intravenous administra- risk factors is prudent and warranted. anticipated level of central nervous tion of sedative medications, though Respiratory and in- system (CNS) depression for dental much more predictable and titrat- 41 44 terruptions in breathing are the most sedation. , able, is also more immediate in likely sedation and anesthetic mishap, There have been theoretical at- onset, forcing the OHCP to recog- and the prudent OHCP should be tempts to define minimal and mod- nize and mange adverse outcomes vigilant in airway maintenance, both erate enteral sedation dosing, and immediately should they occur. through patient selection and the use clinical reports detailing the CNS There may be OHCPs who will 37 of appropriate monitoring. To this depression of triazolam on dental disagree with additional training and

140 JADA 148(3) http://jada.ada.org March 2017 COMMENTARIES expense to deliver the same level of BOX sedation they have always pro- 49 Key takeaways vided, but this guideline change speaks specifically to the philosophy - The most important determinant for safety of dental sedation and general anesthesia is appropriate patient selection and deselection (referral). of “[a]ll dental personnel involved in - The maximum recommended dose for unmonitored home use is the best surrogate for these patient management should be adept same medications in procedural sedation. However, these maximum dosages should serve as the in monitoring vital signs and in ultimate guardrail and should not be considered target doses; rather, do not exceed doses. recognizing and managing life- - More educational opportunities, both didactic and clinical, must be made available for oral threatening emergencies, including health care providers to achieve and maintain competency in providing sedation and anesthesia. - For moderate sedation, the educational requirements should be based on the intended level the ability to rescue the patient from of sedation and appropriate selection and management of these patients and should not be an unintended lapse into a deeper specifically focused on the route of medication administration. 50 level of CNS depression.” The inherent differences between enteral 1. American Dental Association. Guidelines and parenteral aside, once patients patient safety. For minimal seda- tion, the maximum recommended for the use of sedation and general anesthesia by achieve a level of moderate sedation dentists. Adopted by the ADA House of Dele- dose for unmonitored home use is gates, October 2016. Available at: http://www. then the same level of caution to w 20 prevent unintended deepening of the correct surrogate as the ultimate ada.org/ /media/ADA/Education% and% guardrail for these same medica- 20Careers/Files/anesthesia_use_guidelines.pdf? sedation or compromise in airway la¼en. Accessed January 15, 2017. patency must apply, regardless of tions in procedural sedation, but 2. American Dental Association. Guidelines route of drug administration. Pa- they should not be considered for teaching pain control and sedation to target doses, rather, do not exceed dentists and dental students. Adopted by the tients sedated to a moderate level 2016 doses. Educational requirements for ADA House of Delegates, October . either via oral triazolam or an Available at: http://www.ada.org/w/media/ moderate sedation should be based ADA/Education%20and%20Careers/Files/ intravenous are ¼ equally at risk of experiencing on the intended level of sedation, teaching_paincontrol_guidelines.pdf?la en. and appropriate selection and Accessed January 15, 2017. airway-associated morbidity, so the 3. Solana K. ADA House of Delegates adopts training required to provide this management of these patients, and revisions in sedation, anesthesia guidelines. level of sedation to an increasingly not simply the route of medication ADA News. Available at: http://www.ada.org/ administration. No single drug is en/publications/ada-news/2016-archive/ compromised patient population november/ada-house-of-delegates-adopts- should be the same. truly safe and no single level of revisions-in-sedation-anesthesia-guidelines? The approval of Resolution 37 sedation or anesthesia is appro- source¼redirect. Accessed January 15, 2017. 4. Coté CJ, Wilson S. Guidelines for moni- and the recently updated guidelines priate for all patients, therefore OHCPs must understand and toring and management of pediatric patients for the teaching and use of sedation before, during, and after sedation for diagnostic appreciate limitations based on and therapeutic procedures: update 2016. and general anesthesia by OHCPs 2016 38 4 13 39 will not be the last iteration for this patient, drug, and procedural fac- Pediatr Dent. ; ( ): - . tors and the appropriateness of 5. Egerton B. Deadly dentistry. Dallas Morn- evolving document. Sedation and ing News. Available at: http://interactives. n referral. dallasnews.com/2015/deadly-dentistry/. general anesthesia services in the 10 1016 2016 12 030 dental office are essential for the http://dx.doi.org/ . /j.adaj. . . Accessed January 15, 2017. 6. Mirabella L. Mother of teen who died after treatment of dental patients, and Copyright ª 2017 American Dental dental surgery advocates for dental safety. The our profession should never stop Association. All rights reserved. Baltimore Sun. Available at: http://articles. striving for improved efficacy and baltimoresun.com/2013-06-30/news/bs-md-ho- Dr. Goodchild is an associate professor and the dental-awareness-20130630_1_general- safety (Box). To that end, the ADA chairman, Department of Diagnostic Sciences, anesthesia-teeth-wisdom. Accessed January 15, should be commended for contin- Room 210A, School of Dentistry, Creighton 2017. uous and timely updates to the University, 2802 Webster St., Omaha, NE 68131, 7. Gillihan E. Family settles wrongful death guidelines for the teaching and use e-mail [email protected]. Address suit. The Derby Informer. Available at: http:// correspondence to Dr. Goodchild. www.derbyinformer.com/news/derby_news/ of sedation and general anesthesia Dr. Donaldson is the senior executive director, family-settles-wrongful-death-suit/article_416 by dentists. Vizient Pharmacy Advisory Solutions, Irving, 9a3c0-40bc-11e3-8217-0019bb30f31a.html. TX; a clinical professor, School of Pharmacy, Accessed January 15, 2017. CONCLUSIONS University of Montana, Missoula, MT; and a 8. Family files suit after teen dies following clinical assistant professor, School of Dentistry, dental procedure. Laredo Morning Times. The new ADA guidelines for the Oregon Health & Sciences University, Portland, Available at: http://www.lmtonline.com/import/ teaching and use of sedation and OR. article_a410a9ba-7095-53f3-a98d-e497f68e51f8. html. Accessed January 15, 2017. general anesthesia by OHCPs Disclosure. Drs. Goodchild and Donaldson did 9. Kincade K. Woman sues sedation outline 3 levels of sedation and not report any disclosures. training firm over husband’s death. Available at: general anesthesia and encourage http://www.drbicuspid.com/index.aspx? OHCPs to embrace education, The views expressed in this commentary are sec¼ser&sub¼def&pag¼dis&ItemID¼304228. those of the authors and do not necessarily reflect Accessed January 15, 2017. monitoring, and patient assessment those of Creighton University School of Dentistry 10. Wong A. Death of Hawaii toddler points as principal means of ensuring or Vizient. to lax oversight of dentists. The Huffington Post.

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