Remembering the classics: Sedation Guidelines Historical Perspectives Part 1 Foundations:
Charles J. Cote MD
I asked Charlie Cote, a frequent contributor to the PAAD, to review how the classic American Academy of Pediatrics (AAP) sedation guidelines came about. There was so much interesting information in his submission I split it into 2 parts. Part 2 will be published tomorrow. As you read this you’ll note that the late Dr. Ted Striker was involved in the original guidelines. Ted died last year and is greatly missed by all who knew him. Myron Yaster MD
In the early 1980s several children died in dental offices in California as a result of sedation mismanagement. The leadership of the American Academy of Pediatrics (AAP) approached the Section on Anesthesiology of the AAP and asked us to develop a sedation guideline. When you are a young pup as I was at the time, I volunteered to take on this project. Little did I know how much work was involved, the politics of the various players involved in sedation, and that sedation safety would become a life-long passion and transform my academic life. Using my first PC and a program called XY write (before Microsoft Word became dominant), Ted Striker and I and many others produced this first set of sedation guidelines.1
Guidelines for the elective use of conscious sedation, deep sedation, and general anesthesia in pediatric patients. Committee on Drugs. Section on anesthesiology. Pediatrics. Aug 1985;76(2):317-21.
All AAP guidelines must be sent to all Sections of the Academy for comment before publication. At that time I believe there were 20+ sections! We also invited the ASA to join us in the construction of these guidelines. ASA insisted that all sedated children have an IV placed! Obviously an unrealistic requirement for lightly sedated children. Unfortunately, after three meetings ASA dropped out expressing the concern that this guideline would take business away from anesthesiologists! It was also quite interesting to see the various AAP Sections responses. For example, surgeons wanted us to present safe drugs and dosages, in other words to be very proscriptive while the pediatricians tended to not want to initiate the routine use of pulse oximetry and did not want an IV requirement. As a trained pediatrician and anesthesiologist, I was in a unique position to help mediate these concerns. For example, we compromised on the IV issue by inserting wording that stated that someone experienced with starting pediatric IVs must be available rather than requiring an IV (much like we do in the operating room for brief procedures like a myringotomy). Fortunately I had been conducting a study of pulse oximetry that I discussed in a previous PAAD and I presented my preliminary data to the committee and convinced the pediatricians on the value of such monitoring (these data were later published in 1988).2 During the construction of the first guideline we also worked closely with the American Academy of Pediatric Dentistry (AAPD) and used definitions that had been adopted by the American Dental Association and adopted the phrase “conscious sedation”. We greatly regretted adopting that phrase because it was interpreted that any patient movement regardless of their depth of sedation was “conscious” if they moved! Conscious sedation is an oxymoron when it comes to sedating children who generally require pharmacologic restraint to accomplish most procedures safely and atraumatically.
As per the standard AAP practice, all guidelines must be revised every six years. After 1985 we realized that there was a great deal of misunderstanding as to who was supposed to be following these guidelines. Since we had included the phrase “general anesthesia” in the title, most pediatric practitioners thought that the guideline only applied to anesthesiologists. Therefore, at the time of revision we changed the name to reflect what we actually intended: “Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures.”3 emphasizing that monitoring was a continuum and that children had to be monitored during recovery until they could be safely discharged. The guidelines emphasized the importance of a pre-sedation evaluation, appropriate fasting, informed consent, monitoring including pulse oximetry, the use of a time-based record for vital signs the availability of age and size appropriate equipment airway management and resuscitation and appropriately equipped and staffed recovery facility and strict discharge criteria. We also clarified what we meant by various levels of sedation and that “conscious sedation” implied in purposely both of patient and not reflex withdrawal from a painful stimulus. Unfortunately the AAPD withdrew participation in this revision for ill-defined political reasons.
The ASA published their first sedation guideline for non-anesthesiologists in 1996 (4) and I was asked to be the pediatric liaison on that committee. I was able to get much of the language used in the AAP document incorporated into the ASA document. However the ASA document only covered moderate sedation and did not address the issue of deep sedation.
The AAP guideline and the ASA Practice Guidelines were subsequently revised in 2002 (5, 6) in order to unify the descriptive language and definitions used in both documents and to use language identical to the Joint Commission (Table) . Additionally the guideline prohibited the use of home sedative prescriptions. It should be noted that at that time it was common for dentists and radiologists to write prescriptions for chloral hydrate or other sedatives to be given by the parents at home prior to arrival at the facility. A few years prior to this revision I had had the opportunity to obtain adverse sedation event documents reported to the Food and Drug Administration. I also conducted a survey of pediatric anesthesiologists, pediatric intensivists, and pediatric emergency medicine physicians who were members of the AAP in order to find more cases. The cases were debated by an two pediatric anesthesiologists, a pediatric intensivist, and a pediatric emergency room physician and the statistical analysis was conducted gratis by Richard Connis who for many years was statistical advisor to the ASA. After reviewing over 800 documents, we narrowed it down to 95 whereby the four of us agreed upon causation (Roche Pharmaceuticals financially supported this part of the project so that we could meet in one location). The results revealed that 60 children experienced death or neurologic injury as the end point and unexpectedly 29 of them were undergoing dental procedures.7 Had we known beforehand that so many cases would be dental we would have invited a pediatric dentist to participate in this process. Drug interactions, drug overdoses, inadequate monitoring, inadequate rescue skills, inadequate preprocedure evaluation and inadequate numbers of support personnel were major contributing factors. Upon examination of the drugs utilized, there was an equal representation of opioids, benzodiazepines, barbiturates, sedatives, chloral hydrate, and even one case of ketamine associated with these terrible outcomes.8 All routes of administration, oral, nasal, rectal, intramuscular, intravenous, and inhalation (nitrous oxide + other sedating medications) were associated with adverse outcomes. The majority of adverse events, as expected in children, presented initially with evidence of respiratory compromise with the secondary event cardiac arrest. 22 of these events occurred in nonhospital venues, e.g., in a dental office or freestanding radiology facility. At the time because pulse oximetry was not commonly used and only 20 cases reported the use of pulse oximetry; all 15 hospital-based cases were rescued but only 1/5 in the dental office were rescued. We concluded that it wasn’t the drugs or the route of administration, but rather a lack of understanding of the pharmacology, lack of skills of the practitioner administering the drugs and lack of rescue procedures. These data were then used to support the routine use of pulse oximetry for all sedated children and to support the use of capnography for deeply sedated patients.
Intended Depth of Sedation
Must be able to rescue from moderate sedation
Previously called “anxiolysis” e.g., oral midazolam
Must be able to rescue from deep sedation
Airway patency and cardiovascular stability maintained. Previously called “conscious sedation” whereby the patient responds purposefully upon command e.g., squeeze my hand
Must be able to rescue from a state of general anesthesia
Airway patency may or may not be maintained,, cardiovascular instability may occur
1. Guidelines for the elective use of conscious sedation, deep sedation, and general anesthesia in pediatric patients. Committee on Drugs. Section on anesthesiology. Pediatrics. Aug 1985;76(2):317-21.
2. Cote CJ, Goldstein EA, Cote MA, Hoaglin DC, Ryan JF. A single-blind study of pulse oximetry in children. Anesthesiology. Feb 1988;68(2):184-8.
3. American Academy of Pediatrics Committee on Drugs: Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatrics. Jun 1992;89(6 Pt 1):1110-5.
4. Practice guidelines for sedation and analgesia by non-anesthesiologists. A report by the American Society of Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Anesthesiology. Feb 1996;84(2):459-71.
5. Committee on Drugs. American Academy of P. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: addendum. Pediatrics. Oct 2002;110(4):836-8.
6. American Society of Anesthesiologists Task Force on S, Analgesia by N-A. Practice guidelines for sedation and analgesia by non-anesthesiologists. Anesthesiology. Apr 2002;96(4):1004-17.
7. Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. Apr 2000;105(4 Pt 1):805-14.
8. Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. Oct 2000;106(4):633-44.
9. American Academy of P, American Academy of Pediatric D, Cote CJ, Wilson S, Work Group on S. Guidelines for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures: an update. Pediatrics. Dec 2006;118(6):2587-602.
10. Cote CJ, Wilson S, American Academy Of P, American Academy Of Pediatric D. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. Jul 2016;138(1)
11. Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018: A Report by the American Society of Anesthesiologists 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. Anesthesiology. Mar 2018;128(3):437-479.
12. Cote CJ, Wilson S, American Academy Of P, American Academy Of Pediatric D. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures. Pediatrics. Jun 2019;143(6)