Raise the bar for safe sedation, not barriers for access to care

Abstract

Editor’s note: In Goodchild and Donaldson’s commentary (“New Sedation and General Anesthesia Guidelines: Why the Changes?,” on page 138) and this commentary, the 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. Hopefully, 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. The 2016 revised American Dental Association (ADA) guidelines for the use of anesthesia and sedation by dentists proposes to raise the bar for safety by increasing the number of hours and clinical experiences for training in moderate sedation, limiting the dose of drugs administered for minimal sedation, and including assessment of body mass index and obstructive sleep apnea for preoperative patient evaluation.1American Dental Association. Guidelines for the Use of Sedation and General Anesthesia by Dentists. Adopted by the ADA House of Delegates, October 2016. Available at: https://www.ada.org/∼/media/ADA/Education%20and%20Careers/Files/anesthesia_use_guidelines.pdf?la=en. Accessed January 15, 2017.Google Scholar, 2American Dental Association. Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students. Adopted by the ADA House of Delegates, October 2016. Available at: https://www.ada.org/∼/media/ADA/Education%20and%20Careers/Files/teaching_paincontrol_guidelines.pdf?la=en. Accessed January 15, 2017.Google Scholar Benzodiazepines are the drugs most commonly used for both minimal and moderate sedation due to their wide margin of safety as anxiolytic agents. Restricting the dose of drugs with a wide margin of safety for minimal sedation while ignoring other drugs and clinical practices does not raise the bar for safety but potentially raises barriers for the delivery of safe and effective sedation by limiting the number of dentists who will be trained. This commentary suggests additional approaches to improve the safety of sedation and anesthesia for dental outpatients without creating barriers for access to care for those most in need of these services. The accompanying counterpoint by Goodchild and Donaldson3Goodchild J.H. Donaldson M. New sedation and general anesthesia guidelines: why the changes?.JADA. 2017; 148: 138-142Abstract Full Text Full Text PDF Scopus (3) Google Scholar calls attention to other factors that influence safety such as individual variation among patients, drug interactions between sedative drugs and multiple drugs that patients may be taking chronically, and provides a rationale for extrapolating the US Food and Drug Administration maximum recommended dose for insomnia to off-label for outpatient sedation. Numerous risk factors have been identified as determinants of the safety of sedative procedures for dental outpatients.4Dionne R.A. Laskin D.M. Anesthesia and Sedation in the Dental Office. Elsevier, New York, NY1986Google Scholar, 5Williams MR, Ward DS, Carlson D, et al. Evaluating patient-centered outcomes in clinical trials of procedural sedation, part 1 efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations (published online ahead of print September 12, 2016). Anesth Analg. http://dx.doi.org/10.1213/ANE.0000000000001566.Google Scholar, 6American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-AnesthesiologistsPractice guidelines for sedation and analgesia by non-anesthesiologists.Anesthesiology. 2002; 96: 1004-1017Crossref PubMed Scopus (1700) Google Scholar, 7Dionne R.A. Yagiela J.A. Coté C. et al.Balancing efficacy and safety for the use of oral sedation in dental outpatients.JADA. 2006; 137: 502-513Abstract Full Text Full Text PDF PubMed Scopus (43) Google Scholar Many of these factors relate to clinical skills and training that are addressed in the guidelines and, if universally practiced, would enhance safety. But many important determinants of safety are pharmacologic factors: the drugs administered, dose range, route and rate of administration, and the combinations of drugs administered (Figure). Drugs that are used to reduce perioperative anxiety and pain range from having minimal effects on normal physiological function, such as nitrous oxide, to drugs that predictably suppress respiration and the ability of the patient to maintain an airway, for example, opioids and general anesthetics. Differences across drug classes are predictive of the potential safety of drugs used for sedation: benzodiazepines act selectively at the γ-aminobutyric acid receptor to produce anxiety relief with minimal effects on consciousness and respiration, and their effects can be readily reversed with an antagonist acting at that receptor. In contrast, chloral hydrate acts through nonspecific alcohol intoxication to markedly depress consciousness and respiration and cannot be pharmacologically reversed. Moreover, although benzodiazepines such as midazolam and triazolam are rapidly metabolized to inactive metabolites, chloral hydrate is metabolized to trichloroethanol that is slowly metabolized (half-life > 8 hours) and continues to produce depressant effects after the patient leaves the professional supervision of the dental office. The pharmacologic properties of drug classes used for outpatient sedation forms the basis for their risks when used clinically and is predictive of their overall safety. This is reflected in the incidence of serious morbidity and mortality associated with individual drugs and their combinations that produce respiratory and central nervous system (CNS) depression.8Taylor D.M. Bell A. Holdgate A. et al.Risk factors for sedation-related events during procedural sedation in the emergency department.Emerg Med Australas. 2011; 23: 466-473Crossref PubMed Scopus (28) Google Scholar, 9Goudra B, Nuzat A, Singh PM, Borla A, Carlin A, Gouda G. Association between type of sedation and the adverse events associated with gastrointestinal endoscopy: an analysis of 5 years’ data from a tertiary center in the USA (published online ahead of print April 29, 2016). Clin Endosc. http://dx.doi.org/10.5946/ce.2016.019.Google Scholar, 10Bellolio M.F. Gilani W.I. Barrionuevo P. et al.Incidence of adverse events in adults undergoing procedural sedation in the emergency department: a systematic review and meta-analysis.Acad Emerge Med. 2016; 23: 119-134Crossref PubMed Scopus (67) Google Scholar By focusing on the doses of benzodiazepines and related clinical practices used for enteral sedation, the revised guidelines ignore more significant risk factors associated with less safe drugs and combinations used for moderate and deep sedation. Although calls for prospective studies are in the proceedings of the National Institutes of Health Consensus Conference on Anesthesia and Sedation in the Dental Office 30 years ago,4Dionne R.A. Laskin D.M. Anesthesia and Sedation in the Dental Office. Elsevier, New York, NY1986Google Scholar there is still insufficient published data to support the safety of most drugs and combinations used for sedation and anesthesia in the dental office. Potentially informative data from state boards and professional liability insurers on serious morbidity and mortality are often not made available for evaluation of the relationship between determinants of safety and actual adverse events occurring in clinical practice. Although case series represent a low level of scientific evidence, reports in the public domain of deaths related to anesthesia or sedation in dental outpatients11Egerton B. Deadly dentistry. Dallas Morning News. Available at: http://interactives.dallasnews.com/2015/deadly-dentistry/. Accessed January 15, 2017.Google Scholar do not support a focus on benzodiazepines, in particular triazolam. Combinations of 2 or more CNS depressant drugs are more prevalent in case reports of serious morbidity and mortality, consistent with findings from clinical trials.12Dionne R.A. Yagiela J.A. Moore P.A. Gonty A. Zuniga J. Beirne O.R. Comparing efficacy and safety of four intravenous sedation regimens in dental outpatients.JADA. 2001; 132: 740-751Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar This observation is consistent with a US Food and Drug Administration action issuing a black box warning for 389 opioid and benzodiazepine drugs recommending that drugs from these 2 classes should not be coadministered unless there is no alternative treatment available.13U.S. Food & Drug Administration. FDA Drug Safety Communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. Available at: www.fda.gov/Drugs/DrugSafety/ucm518473.htm. Accessed January 20, 2017.Google Scholar The single operator-anesthetist is also a risk factor for the use of anesthetic and sedative drugs, as the dentist performing the clinical procedure is ultimately responsible for monitoring the patient at the same time. There is little evidence to suggest that the use of a minimally trained dental assistant abrogates the potential risks of a single operator-anesthetist when drugs are administered that produce general anesthesia or deep sedation.14Bennett J.D. Kramer K.J. Bosack R.C. How safe is deep sedation or general anesthesia while providing dental care?.JADA. 2015; 146: 705-708Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar If the public can appreciate that driving and texting at the same time is an unsafe practice, the dental profession needs to justify the continued risk of the single operator-anesthetist that places economic benefit over patient safety. Although graded doses of a drug results in a greater magnitude of response as the dose is increased (the dose-response relationship), wide interpatient variability in pharmacokinetics and pharmacodynamics limits the ability to predict the responses across patients. Even with the highest level of training, anesthesia and deep sedation performed in an optimal outpatient setting can result in serious morbidity and mortality.15Mirabella L. Mother of teen who died after dental surgery advocates for dental safety. The Baltimore Sun. Available at: http://articles.baltimoresun.com/2013-06-30/news/bs-md-ho-dental-awareness-20130630_1_general-anesthesia-teeth-wisdom. Accessed January 15, 2017.Google Scholar, 16Smith T. Virginia Medicaid agency probes boy’s death after dental work. Richmond Times Dispatch. Available at: www.richmond.com/news/article_1fb96026-7d5e-5c82-9c5a-5a4bd4f2be1c.html. Accessed January 15, 2017.Google Scholar Reliance on monitoring and the ability to manage adverse events in the dental office is problematic, as resuscitation in a hospital setting even by highly trained code teams that respond rapidly has a low success rate (13-15%).17Schneider 2nd, A.P. Nelson D.J. Brown D.D. In-hospital cardiopulmonary resuscitation: a 30-year review.J Am Board Fam Pract. 1993; 6: 91-101PubMed Google Scholar, 18Ravakhah K. Khalafi K. Bathory T. Wang H.C. Advanced cardiac life support events in a community hospital and their outcome: evaluation of actual arrests.Resuscitation. 1998; 36: 95-99Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar Whereas an inpatient setting often involves seriously ill patients who are less likely to be successfully resuscitated, most dentists do not have the level of training of an inpatient code team to resuscitate a patient who has experienced respiratory or cardiac arrest. Preventive strategies to minimize the likelihood of adverse events that can precipitate serious morbidity or mortality include limiting the parenteral administration of opioids for moderate or deep sedation and reserving the use of deep sedation or general anesthesia for special patients or highly phobic patients who would otherwise not tolerate indicated dental treatment. Balancing the therapeutic need for additional CNS depressant drugs with their greater risk of experiencing respiratory depression can be optimized by not exposing all patients to the risk of an opioid if adequate regional anesthesia and a benzodiazepine provide the desired therapeutic outcome. Minimal sedation in a dose range of 0.125 to 0.5 milligrams of triazolam (adjusted for known risk factors such as age, body mass index, and medical history) combined with effective regional anesthesia produces anxiety reduction comparable to a dose of parenterally administered diazepam producing moderate sedation,19Kaufman E. Hargreaves K.M. Dionne R.A. Comparison of oral triazolam and nitrous oxide with placebo and intravenous diazepam for outpatient premedication.Oral Surg Oral Med Oral Pathol. 1993; 75: 156-164Abstract Full Text PDF PubMed Scopus (14) Google Scholar, 20Berthold C.W. Dionne R.A. Corey S.E. Comparison of sublingually and orally administered triazolam for premedication prior to oral surgery.Oral Surg Oral Med Oral Pathol Endo. 1997; 84: 119-124Abstract Full Text PDF PubMed Scopus (24) Google Scholar but without the potential risks of parenteral sedation. Addressing the dichotomy in the benefit-to-risk relationships between minimal, moderate, and deep sedation may more effectively prevent morbidity and mortality than regulating the use of the safer clinical practice.The ethical imperative to “first, do no harm” includes the safety of anesthesia and sedation practices. The ethical imperative to “first, do no harm” includes the safety of anesthesia and sedation practices. The ethical imperative to “first, do no harm” includes the safety of anesthesia and sedation practices. Providing assurances of safety to patients in the absence of definitive data to support the risks of the varying levels of sedation and anesthesia may broach professional ethics, especially if their use is being promoted to patients for marketing purposes. The dental profession has long recognized the need to limit “Painless Parker” claims by dental practitioners and should recognize that promotion to patients that any level of sedation is inherently safe in the absence of supportive data in the era of evidence-based dentistry is misleading. Practitioners are also placed at risk by providing anesthesia and sedation services that predictably result in serious morbidity or mortality as reports in the public domain not only put the profession in an unfavorable light,11Egerton B. Deadly dentistry. Dallas Morning News. Available at: http://interactives.dallasnews.com/2015/deadly-dentistry/. Accessed January 15, 2017.Google Scholar individual dentists often lose their privilege to practice,21Walsh P. Teen’s death after oral surgery prompts suspension of Edina dentist’s license. Star Tribune. Available at: www.startribune.com/teen-s-death-after-oral-surgery-prompts-suspension-of-edina-dentist-s-license/369660871/. Accessed January 15, 2017.Google Scholar, 22Fowler T. Connecticut dentist charged with negligent homicide after patient dies while having 20 teeth pulled. People. Available at: http://people.com/crime/dentist-rashmi-patel45-arrested-for-patients-death/. Accessed January 20, 2017.Google Scholar and, in the extreme, are subject to litigation and criminal charges.22Fowler T. Connecticut dentist charged with negligent homicide after patient dies while having 20 teeth pulled. People. Available at: http://people.com/crime/dentist-rashmi-patel45-arrested-for-patients-death/. Accessed January 20, 2017.Google Scholar, 23Irvington dentist probed after 2nd child dies in his care. The Star-Ledger. Available at: http://www.nj.com/news/index.ssf/2012/02/irvington_dentist_probed_after.html. Accessed January 20, 2017.Google Scholar Recommendations to improve the safety of anesthesia and sedation by dentists include the following.⁃Urge state dental boards and liability carriers to release redacted data on serious morbidity and mortality for scientific review. The policies of state dental boards and liability carriers to not disclose potentially informative data on the drugs, doses, monitoring, or physical risk factors associated with deaths attributed to sedation and anesthesia practices leads the public to assume that something is being hidden.11Egerton B. Deadly dentistry. Dallas Morning News. Available at: http://interactives.dallasnews.com/2015/deadly-dentistry/. Accessed January 15, 2017.Google Scholar The profession can take leadership by encouraging state boards and liability carriers to make available redacted information about reported and settled cases to both identify problematic clinical practices and provide assurance to the public about safe practices.⁃Foster the development of prospective research on the safety of anesthesia and sedation through practitioner networks. It may have been excusable for the National Institutes of Health consensus panel to conclude that “the drug groups used for sedation or general anesthesia in the dental office are essentially the same as those used in the hospital setting” based on expert opinion 30 years ago,4Dionne R.A. Laskin D.M. Anesthesia and Sedation in the Dental Office. Elsevier, New York, NY1986Google Scholar but the dental profession now clearly recognizes the need to base clinical practices on scientific evidence. Development of prospective data collection on the risks of sedation and anesthesia, adverse outcomes, and the number of procedures performed can be readily implemented in an era of big data, wireless data collection devices, and practitioner networks. The ADA could encourage initiation of prospective morbidity and mortality data collection within existing practice networks and foster this strategy through development of standardized methods for both the use of sedation and anesthesia, and as part of formalized training programs. The ADA guidelines usually form the basis for state regulations that could go beyond requirements to report deaths and serious morbidity (the numerator) by also collecting prospective data on the number and characteristics of procedures performed at the various levels of sedation (the denominator).⁃Encourage training in minimal and moderate sedation, and the management of sedation-related adverse events at the doctoral and postdoctoral levels. Training in sedation and anesthesia at the doctoral level is minimal at many schools of dental medicine and often is not taught to proficiency in residency programs. The ADA and American Dental Education Association could work together to develop educational guidelines for teaching minimal sedation at the doctoral and postgraduate level, and encourage their implementation through the accreditation process. Similarly, moderate sedation could be taught in hospital-based programs to the standards in the guidelines. Both of these approaches would eventually negate the need for “hotel courses” that are often questionable as adequate training.⁃Critically re-evaluate the evidence for the safety and rationale for sedation modalities used in clinical practice. Continuing to assert the safety of clinical practices for outpatient sedation and anesthesia based on expert opinion in the face of growing public concern leaves open the possibility of limitations being imposed by legislative actions and jeopardizes reimbursement as a validated clinical practice. Attempting to limit the doses used for the safest form of sedation (minimal) by invoking a fallacious surrogate end point for safety, the maximum recommended dose for unsupervised use at home for the treatment of insomnia, does not adequately address the safety of drugs, doses, and routes of administration if other less safe drug classes are not evaluated. The published evidence provides a starting point for critical review of the safety of drugs and combinations in use that could eventually form the basis for evidence-based guidelines for clinical practice. This process could be designed to minimize professional biases and self-interest that may be influencing the push for guidelines to regulate the use of enteral sedation by general dentists while ignoring potentially higher risk practices by specialty groups. Dentists have historically been leaders in the development of general anesthesia, regional anesthesia, and safe sedation. Although the promotion of enteral sedation with high doses of triazolam (> 0.5 mg) has likely contributed to the efforts to regulate its use, other nonvalidated clinical practices also need to be critically re-examined based on the evidence that the doses, drugs, drug combinations, and clinical practices contribute to serious morbidity and mortality. Personal preference for sedative drugs and combinations is an inadequate justification for clinical practices that inevitably contribute to preventable morbidity and mortality. A failure to effectively and ethically self-regulate will contribute to continued widespread media reports of deaths associated with anesthesia and sedation that discredit the profession, ruin the professional careers of the dentists named in these reports, and invite legislative interventions with an unpredictable outcome. For example, based on reports of 2 deaths, the United Kingdom now prohibits the use of general anesthesia in dental practices.24Landes D.P. The provision of general anesthesia in dental practice, an end which had to come?.Br Dent J. 2002; 192: 129-131Crossref PubMed Scopus (11) Google Scholar Is this the appropriate legacy of Horace Wells (credited with the discovery of general anesthesia), Leonard Monheim (a pioneer in the use of anesthesia and sedation by dentists), Harry Langa (who popularized the use of nitrous oxide for anxiety relief in dentistry), and others? It is time to make evidence-based sedation and anesthesia practices the ultimate criteria for patient safety, not expert opinion and political compromise to justify continuation of nonvalidated clinical practices. Dr. Dionne is a research professor, Department of Pharmacology and Toxicology, Brody School of Medicine, and a research professor, Department of Foundational Sciences, School of Dental Medicine, East Carolina University, Greenville, NC. Dental operator-anesthetistsThe Journal of the American Dental AssociationVol. 148Issue 7PreviewI appreciated Dr. Raymond Dionne’s circumspect anesthesia commentary in March JADA (“Raise the Bar for Safe Sedation, Not Barriers for Access to Care” JADA. 2017;148[3]:133-137); however, I must comment on 1 paragraph. Full-Text PDF