Concerns Regarding the Single OperatorRita Agarwal, MD,a​ Anna Kaplan, Model MD,​b Raeford Brown, of MD, c​Sedation Charles J. Coté, MDd in Young Children

’ In July 2016, the American Academy recommended general anesthesia. of Pediatrics (AAP) and the American Caleb s parents did not consent lightly Academy of Pediatric Dentistry to this method of anesthesia. They “ (AAPD) released their joint updated talked through the options with their Guidelines for Monitoring and doctors, family, and friends. They knew Management of Pediatric Patients of the minimal but serious risks of Before, During, and After Sedation anesthesia. However, our family had ” for Diagnostic1 and Therapeutic no idea or reason to know that dentists Procedures. ‍ The purpose of this and oral surgeons provide anesthesia aDepartment of Anesthesiology, Perioperative Medicine, update, as stated by the authors and significantly differently than the and Pain Management, School of Medicine, Stanford “ University, Stanford, California; bCaleb’s Law; cDepartment supported by the AAP and AAPD, medical’ model. of Anesthesiology, University of Kentucky, Lexington, was to unify the guidelines for Kentucky; and dDepartment of Anesthesiology, Critical Care Caleb s surgery occurred in a sedation used by medical and dental and Pain Management, Harvard Medical School, Harvard … private office with an oral surgeon University, Boston, Massachusetts practitioners; to add clarifications and 2 dental assistants. There was regarding monitoring modalities ; All authors contributed to the conceptualization of no dedicated separate anesthesia to provide updated information from the manuscript after the adoption of the American provider, not even a nurse present. The Academy of Pediatrics Annual Leadership Forum: the medical and dental literature; ” oral surgeon administered fentanyl, Resolution 42, “Not One More Child Shall Die in a and to suggest methods for further midazolam, propofol, and ketamine Dental Chair: Remembering Caleb”; Dr Kaplan is improvement in safety and outcomes. ’ the author of California’s Caleb’s Law and AB 224; intravenously, then went to work on They described the substantial Drs Agarwal, Coté, and Kaplan did considerable Caleb s teeth. No one noticed that differences between sedation for research on sedation safety and complications; Caleb had stopped breathing until the Dr Brown reviewed and revised the manuscript; children and adults, and emphasized pulse oximeter read 69%. and all authors approved the final manuscript the subtlety and rapidity with which as submitted and agree to be accountable for all young children can pass from 1 level of Rescue efforts appeared to be aspects of the work. sedation to another unintended level. woefully inadequate. According to the DOI: https://​doi.​org/​10.​1542/​peds.​2017-​2344 The need to have practitioners that can available records, no one attempted Accepted for publication Nov 9, 2017 quickly recognize the signs of deeper bag and/or mask ventilation. The Address correspondence to Rita Agarwal, MD, levels of sedation and have the skills, oral surgeon attempted intubation Department of Anesthesiology, Perioperative equipment, and support personnel to (knocking out a number of teeth) Medicine and Pain Management, Stanford rescue the child from potential adverse and was unsuccessful; he attempted University Hospital, 300 Pasteur Dr, Stanford, CA responses to these unintended levels of cricothyroidotomy and was also 94305. E-mail: [email protected] sedation is critical. unsuccessful. There was no attempt PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, Caleb’s Story by Anna Kaplan, MD, to insert a nasal trumpet, oral airway, 1098-4275). Caleb’s Aunt or laryngeal mask airway. More Copyright © 2018 by the American Academy of importantly, despite having an IV in Pediatrics place, there was no attempt to reverse My nephew Caleb was a strong, the fentanyl or midazolam. When the ’ To cite: Agarwal R, Kaplan A, Brown R, et al. healthy, 6-and-a-half year old when paramedics arrived, no one was doing Concerns Regarding the Single Operator Model he died. Caleb was scheduled to cardiopulmonary resuscitation. Caleb s of Sedation in Young Children. Pediatrics. 2018; have a mesiodens tooth extracted, a electrocardiogram showed pulseless 141(4):e20172344 supernumerary tooth between the 2 electrical activity. He had been without central incisors. His oral surgeon had oxygen for at least 20 minutes. In Downloaded from www.aappublications.org/news by guest on October 2, 2021 PEDIATRICS Volume 141, number 4, April 2018:e20172344 Family Partnerships the emergency department, he had deep experience with child especially suspect, given that dentists was immediately and successfully health advocacy. Two authors (C.J.C., and oral surgeons usually bill their ’ intubated, but it was too late. For R.A.) provided background and patients separately for surgery and the next 48 hours, our family stood testimony as witnesses for hearings anesthesia. Caleb s oral surgeon, by Caleb in the PICU as his medical and meetings with legislators and for example, billed $670 for the condition deteriorated, until finally, broadened the coalition of academics procedure and $755 for the general ’ a neurologist told us he had passed. that were now advocating for anesthesia. Caleb s parents held him as he was change. The California Society of Caleb was a completely healthy child. removed from the ventilator. Anesthesiologists and the California He did not have an allergic reaction Society of Dentist Anesthesiologists Over the next months, our family or a latent heart defect. His death ’ also joined us with support of provided support as best we could was completely preventable. Had the bill. Together this coalition, for Caleb s devastated parents. This a medically skilled independent which included our family, worked profound personal loss spurred our clinician as recommended by the to shepherd the bill through the family to educate ourselves further AAP/AAPD guidelines been used, ’ legislature and to the governor for regarding dental practice models and ’ Caleb would likely not have died. signature. This became known as procedures. Looking beyond Caleb s Instead, 2 medically unskilled Caleb’s Law Part 1. case, it was surprising to learn that and inadequately trained dental this was a common model in dental Caleb s Law Part 1 (www.​ assistants were unable to assist, ’ practice. Our family discovered that calebslaw.​org) passed in 2016 and chaos ruled, and a tragedy occurred. Caleb s death was not an isolated accomplished 3 important changes: Discussion incident, but no one was doing (1) it mandated improved data anything to change it. We set out collection by the Dental Board of to shine a light on this issue and California by requiring them to Younger children are recognized to hopefully prevent other families from collect specified epidemiologic ’ be at increased risk for side effects suffering similar unimaginable losses. information for each adverse event ’ and complications with sedation Caleb s Law began when our family and encouraged the dental board to and/or anesthesia. The medical (Caleb s mother and father, my contract with a nonprofit anesthesia community routinely follows the husband, and myself) met with our registry to begin real-time data AAP/AAPD and the American Society California State Assembly member collection for sedation encounters in of Anesthesiologists (ASA) guidelines Tony Thurmond. We described what the dental office; (2) mandated that regarding procedural sedation. The had happened to Caleb and proposed the dental board perform a study AAP/AAPD“ guidelines state: a bill to make dental anesthesia safer. of sedation safety; and (3) specified During deep sedation, there must’ be 1 I worked closely with Mr Thurmond the contents of a disclosure form person whose only responsibility is to to both draft a bill and present it to for parents concerning anesthesia- constantly observe the patient s vital the State Assembly. related risks in a dental setting. signs, airway patency, and adequacy of ventilation and to either administer The first version of the bill proposal The California Dental Board drugs or direct their administration. drafted by our family required completed their study in December This individual must, at a minimum, be trained in PALS [Pediatric Advanced Life that there be a dedicated qualified 2016. Our family and Assemblyman Support] and capable of assisting with anesthesia provider to monitor Thurmond, together with the AAP-CA, any emergency event. At least 1 individual pediatric patients undergoing deep have now sponsored a new 2-year must be present who is trained in and sedation or general anesthesia. bill to codify these recommendations, capable of providing advanced pediatric This version of the bill hit major which include among several others life support and who” is skilled to rescue a child with apnea, laryngospasm, and/or opposition from the California that there should be a separate 1 airway obstruction. ‍ Dental Association and the California anesthesia provider for young Association of Oral and Maxillofacial children undergoing deep sedation In hospitals, clinics, offices, and ’ Surgeons. The American Academy and general2 anesthesia. This bill, AB most places where moderate or of Pediatrics, California (AAP-CA), 224,​ is known as Caleb s Law Part 2. deep sedation is practiced in young a 501(c)4 separately incorporated However, the dental lobby continues children, the person monitoring from the national AAP, stepped in to challenge the recommended the patients and administering the as the sponsor of the legislation. changes, arguing that there are medications is at least a qualified The AAP-CA provided clout and insufficient data to justify change and nurse, and most often a physician. credibility. They helped us muster ’ that a separate anesthesia provider Most institutions require significant lobbying resources, physicians eager would increase costs to patients and additional training or education for to testify for children s safety, and decrease access to care. This point is all clinicians involved in sedation Downloaded from www.aappublications.org/news by guest on October 2, 2021 2 Agarwal et al TABLE 1 Level of Education Required in Dental Paraprofessional Positions Level of Education Basic Advanced Dental assistant High school On-the-job, certificate course Dental anesthesia assistant High school, 12 mo practice Online education (36 h), national examination Dental sedation assistant (CA) High school, 12 mo practice On-site, hands on, and online education (110 h); state examination Dental hygienist 2–4 y dental hygienist Associate or (less commonly) bachelor’s degree, national certifying examination Adapted from Boynes SG. Dental Anesthesiology: A Guide to the Rules and Regulations of the United States of America. 5th ed. Chicago, IL: No-No Orchard Publishing; 2011; Dental Anesthesia Assistant National Certification Examination. Available at: www.aaoms.​ ​org/continuing-​ education/​ ​certification-​program-​daance. Accessed June 2017; and Dental Board of California. How to become a dental sedation assistant permit holder. Available at: www.dbc.​ ​ca.​gov/​verification/​index.shtml.​ Accessed May 15, 2017. CA, California.

services. Sedation modules, and death from anesthesia in dental help is by calling 911, which may courses, and hands-on workshops offices as compared with medical take many minutes and may have 4,5​ ’ are taught locally and nationally settings. ‍ The requirements for emergency medical technicians who and include airway management the education and training of dental lack skills to manage a child s airway. workshops. Both the Food and assistants vary considerably from The dental office is in fact a high- “ 6 Drug Administration and the ASA state to state. They often have no risk venue, which makes adequate specifically state propofol used for more than a high school education, skilled staffing even more important. sedation or anesthesia should be with many having only on-the-job With the single operator model, the administered only by persons trained training (Table 1). A dental assistant dentist or oral surgeon would have to in the administration of general in most states is not licensed to draw simultaneously manage the airway, anesthesia and not involved in the draw up and/or administer rescue ” up or administer medications, cannot conduct of the3 surgical/diagnostic perform airway rescue maneuvers, medications, recognize and run the procedure. ‍ and in all likelihood does not have code, and manage cardiopulmonary ’ the education or training to recognize resuscitation. This is an impossible In contrast to physicians offices and changing levels of sedation. There task for even the most skilled clinics, the dentists and oral surgeons is a Dental Assistant Anesthesia clinician. often use the single operator model. National Certification Examination ’ In medicine, adverse events are The single operator model allows that requires 36 hours of online routinely reported to the institution s for 1 anesthesia permit holder (as education and the successful 7 quality improvement or risk defined by the state in which the passage of an online examination. management offices. Additionally, dentist or oral surgeon is practicing) This certification is required in a multiple national agencies (Joint to administer both the sedatives few states (WA, OR) for a dental Commission, Food and Drug and/or anesthetics and perform the assistant (or in some cases dental Administration, Centers for Disease dental work. Each individual state hygienists) to be allowed to monitor Control and Prevention, etc) and determines the requirements for and assist with sedation of children. societies have developed databases licensing and scope of practice. Many The Dental Assistant Anesthesia to collect as much information on of these practitioners will have a National Certification Examination these events as possible, with the dental assistant help monitor the still does not qualify participants to intent to understand faulty processes patient. The American Association of draw up or independently administer and improve outcomes. The same Oral and Maxillofacial Surgeons had medications. California has a Dental data collection does not occur in Sedation Assistant Certification published guidelines approving oral dentistry. The state dental boards that requires 110 hours of in-office ’ surgeons to administer anesthesia 8 are the sole recipient of these data. with only 2 dental assistants for education and training. Advanced ’ Before the passage of Caleb s Law cardiac life support and PALS support. They justify this practice ’ in California and the simultaneous training are not required, although by claiming that 1 dental assistant s review of dental sedation practices Caleb s Law Part 2 (AB 224), which only job is to monitor the patient in Texas, not 1 dental board in all 50 is currently being reviewed in the while the other assists the dentist. states was systematically tracking California State Assembly, would The oral surgeon in this model is these data. This year, Texas and require PALS training. The only the only one trained in anesthesia, California will be the first 2 states to person capable of administering sedation, resuscitation, and medical start tracking’ data on adverse events. care. State dental boards do little to medications and assisting with track adverse outcomes in dental airway emergencies is the dentist When Caleb s family evaluated their offices despite the authors of or oral surgeon performing the anesthesia options, they calculated several medical articles reporting procedure. Thus, the only backup for the risks on the basis of the dominant disproportionate rates of injury rapidly summoning additional skilled medical model. They had no reason Downloaded from www.aappublications.org/news by guest on October 2, 2021 PEDIATRICS Volume 141, number 4, April 2018 3 to consider that their oral surgeon findings can be compared with the of skilled personnel to successfully would administer anesthesia Wake Up Safe initiative (sponsored by rescue the child. and conduct the procedure the Society for Pediatric Anesthesia), Conclusions simultaneously. Dentists and oral which gathers data on the risk surgeons have been able to provide and incidence of complications10,11​ in anesthesia services on the basis of pediatric anesthesia. ‍ Wake Up The AAP has made a commitment the reputation of safety created by Safe is an organization of 32 pediatric to improving care for children the medical community, without anesthesia departments designed undergoing dental sedation, disclosing to the patients that they to reduce the risk and incidence of encouraging all practitioners to fail to follow the same standards. complications in pediatric anesthesia follow the AAP/AAPD guidelines. The Those who argue for the continuation Annual Leadership Forum included by gathering, interpreting, and ’ ’ of the single operator model cite a taking action on data collected from a resolution on preventing deaths in lack of data to prove that this practice these departments. Hospitals and dentists and oral surgeons offices16 is any less safe than having a separate institutions voluntarily share their as 1 of their Top 10 Resolutions. qualified anesthesia provider. This é deidentified morbidity and/or Some states make the single operator argument is disingenuous.4,5​ Over 15 mortality information as well as model of sedation and/or anesthesia years ago, Cot et al ‍ reported 29 their total numbers of cases and more difficult to practice, and the deaths or permanent neurologic demographics. There have been Alberta and British Columbia Dental injury in dental offices, with failure no anesthesia-related deaths or Association have permanently to rescue a nonbreathing child neurologic injuries in almost 2 suspended17 the single operator contributing to 80% of adverse million healthy children (D. Tyler, model. As advocates for the safety outcomes. The Anesthesia Patient MD, personal communication, of all children, we must persevere Safety Foundation, the Anesthesia http://wakeupsafe.​ ​org, 2017). until the same rules and guidelines Incident Reporting System, and other Another database, the Pediatric apply to all children undergoing deep databases that collect information on 11 sedation or general anesthesia in all Sedation Research Consortium,​ is anesthesia or sedation complications locations, in all states, and in all types a collaborative, multi-institutional, have had minimal submissions for of practices. Physicians can advocate multidisciplinary group dedicated dental sedation and/or anesthesia, so – for these changes by contacting their to making pediatric sedation the true incidence is unknown. 12 14 local AAP chapters and districts safer and more effective. ‍‍ All or state senators and/or assembly Journal of the American Dental sedations performed in participating The authors of a 2015 article in members and offer to help craft Association institutions, offices, and clinics the legislation similar to what is being regardless of specialty are reported, examined the incidence done in California. It is unacceptable including data from a few dental of death or brain injury in patients that healthy children continue to providers. There are currently 48 undergoing deep sedation or general die or sustain permanent neurologic participating institutions. There anesthesia by an oral surgeon who injury because a single provider was have been no deaths or significant is also doing the procedure9 (single unable to rescue the child from an operator model). They used the Oral complications in over 500000 evolving adverse event. Pediatricians and Maxillofacial Surgery National reported cases to date (J. Cravero, can educate parents about the risks Insurance Company anesthesia MD, personal communication, ∼ of sedation, and encourage them to closed-claims database from 2000 to Past President and Co-Founder of ask questions (HealthyChildren.org). 2013; this company insures 80% the Pediatric Sedation Research ∼ Abbreviations of practicing oral and maxillofacial Consortium, 2017). Although there surgeons. They determined that 39 have been adverse events,15,​ each was million anesthetics were performed managed successfully. Thus, the AAP: American Academy of in adults and children, and 113 morbidity and mortality of healthy Pediatrics deaths or brain injuries occurred. children ranking as a I or II on the AAPD: American Academy of They estimated that 1 case of death ASA scale who are undergoing either Pediatric Dentistry or brain injury occurs for every general anesthesia or procedural AAP-CA: American Academy of 348602 anesthetics, and at least 1 sedation reported by these initiatives Pediatrics, California instance or more occurred nationally (0 of 500000 to 0 of 2000000) ASA: American Society of every month. These complications appear to be well below that reported Anesthesiologists are occurring in presumably healthy from the dental community in healthy PALS: pediatric advanced life patients of all ages, undergoing minor children and adults (1 of 348602), support noninvasive procedures. These likely because of the ready availability Downloaded from www.aappublications.org/news by guest on October 2, 2021 4 Agarwal et al FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose. FUNDING: No external funding. POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

References 1. Coté CJ, Wilson S; American Academy 7. American Association of Oral and procedural sedation complication of Pediatrics; American Academy Maxillofacial Surgeons. Dental rates. Pediatrics. 2011;127(5). Available of Pediatric Dentistry. Guidelines Anesthesia Assistant National at: www.​pediatrics.​org/​cgi/​content/​ for monitoring and management of Certification Examination (DAANCE). full/​127/​5/​e1154 pediatric patients before, during, Available at: www.​aaoms.​org/​ 13. Davidovich E, Meltzer L, Efrat J, Gozal and after sedation for diagnostic and continuing-​education/​certification-​ D, Ram D. Post-discharge events therapeutic procedures: update 2016. program-​daance. Accessed June 1, occurring after dental treatment under Pediatrics. 2016;138(1):20161212 2017 deep sedation in pediatric patients. 2. AB 224, 2017-18 Leg, 1st Sess (CA 2017) 8. Dental Board of California. License J Clin Pediatr Dent. 2017;41(3):232–235 3. US Food and Drug Administration, et verification. Available at: www.​dbc.​ca.​ 14. Patel MM, Kamat PP, McCracken CE, al .Drugs/ Diprivan. 2017. Available gov/​verification/​index.​shtml. Accessed Simon HK. Complications of deep at: https://​www.​accessdata.​fda.​ May 15, 2017 sedation for individual procedures gov/​drugsatfda_​docs/​label/​2017/​ 9. Bennett JD, Kramer KJ, Bosack (lumbar puncture alone) versus 019627s066lbl.​pdf. Accessed May 15, RC. How safe is deep sedation or combined procedures (lumbar 2017 general anesthesia while providing puncture and bone marrow aspirate) dental care? J Am Dent Assoc. in pediatric oncology patients. Hosp 4. Coté CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse 2015;146(9):705–708 Pediatr. 2016;6(2):95–102 sedation events in pediatrics: analysis 10. Kur th CD, Tyler D, Heitmiller E, 15. Peña BM, Krauss B. Adverse events of of medications used for sedation. Tosone SR, Martin L, Deshpande JK. procedural sedation and analgesia in a Pediatrics. 2000;106(4):633–644 National pediatric anesthesia safety pediatric emergency department. Ann quality improvement program in Emerg Med. 1999;34(4, pt 1):483 491 5. Coté CJ, Notterman DA, Karl HW, – Weinberg JA, McCloskey C. Adverse the United States. Anesth Analg. 16. American Academy of Pediatrics. About sedation events in pediatrics: a critical 2014;119(1):112–121 the AAP Leadership. 2017. Available incident analysis of contributing 11. Society for Pediatric Sedation. at: https://​www.​aap.​org/​en-​us/​about-​ factors. Pediatrics. 2000;105(4, pt Pediatric Sedation Research the-​aap/​aap-​leadership/​Pages/​default.​ 1):805–814 Consortium. 2017. Available at: www.​ aspx. Accessed March 12, 2017 6. Boynes SG. Dental Anesthesiology: A pedsedation.​org/​resources/​research/​. 17. Alber ta Dental Association and Accessed May 13th 2017 Guide to the Rules and Regulations of College. Media release—August the United States of America. 5th ed. 12. Couloures KG, Beach M, Cravero 17, 2017. Available at: http://​www.​ Chicago, IL: No-No Orchard Publishing; JP, Monroe KK, Hertzog JH. Impact dentalhealthalberta.​ ​ca/​index/​Pages/​ 2011 of provider specialty on pediatric media-​room

Downloaded from www.aappublications.org/news by guest on October 2, 2021 PEDIATRICS Volume 141, number 4, April 2018 5 Concerns Regarding the Single Operator Model of Sedation in Young Children Rita Agarwal, Anna Kaplan, Raeford Brown and Charles J. Coté Pediatrics 2018;141; DOI: 10.1542/peds.2017-2344 originally published online March 2, 2018;

Updated Information & including high resolution figures, can be found at: Services http://pediatrics.aappublications.org/content/141/4/e20172344 References This article cites 9 articles, 4 of which you can access for free at: http://pediatrics.aappublications.org/content/141/4/e20172344#BIBL Subspecialty Collections This article, along with others on similar topics, appears in the following collection(s): Dentistry/Oral Health http://www.aappublications.org/cgi/collection/dentistry:oral_health_s ub Anesthesiology/Pain Medicine http://www.aappublications.org/cgi/collection/anesthesiology:pain_m edicine_sub Permissions & Licensing Information about reproducing this article in parts (figures, tables) or in its entirety can be found online at: http://www.aappublications.org/site/misc/Permissions.xhtml Reprints Information about ordering reprints can be found online: http://www.aappublications.org/site/misc/reprints.xhtml

Downloaded from www.aappublications.org/news by guest on October 2, 2021 Concerns Regarding the Single Operator Model of Sedation in Young Children Rita Agarwal, Anna Kaplan, Raeford Brown and Charles J. Coté Pediatrics 2018;141; DOI: 10.1542/peds.2017-2344 originally published online March 2, 2018;

The online version of this article, along with updated information and services, is located on the World Wide Web at: http://pediatrics.aappublications.org/content/141/4/e20172344

Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it has been published continuously since 1948. Pediatrics is owned, published, and trademarked by the American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 2018 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.

Downloaded from www.aappublications.org/news by guest on October 2, 2021