Remembering the classics: Pediatric Sedation Research Consortium
Joseph P. Cravero MD
Today’s PAAD, a remembering the classics, is by Dr. Joseph (“Joe”) P. Cravero, MD, one of the pioneers investigating the safety and quality of pediatric sedation outside of the operating room, regardless of who provides it. For those (unfortunate of) you who don’t him, Joe is the Anesthesiologist-in-Chief at Boston Children’s Hospital and Professor of Anesthesia at Harvard Medical School. He is the Milton H. Alper Chair in Pediatric Anesthesia Outcomes Research and is the founder of the Society for Pediatric Sedation and the Pediatric Sedation Research Consortium. He has served as a section editor for the Journal Pediatric Anesthesia for 15 years and is on the editorial board of Anesthesia and Analgesia. He is also a Senior Examiner for the American Board of Anesthesiology.
As regular readers of the PAAD know, one of my goals in a remembering the classics article is to have one of the original authors not only describe the results of their research but to also provide the back story of how and why the research was conducted and obstacles the research team had to overcome to complete and publish their research. Myron Yaster MD
Original article
Cravero JP, Blike GT, Beach M, Gallagher SM, Hertzog JH, Havidich JE, Gelman B: Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006; 118: 1087-1096. 1 PMID: 16951002
I am paraphrasing here, but Myron once wrote in an editorial that “pediatric sedation is the la brea tarpit of pediatrics”.2 Although I could never come up with such colorful language, I fundamentally agree that this area of pediatric medicine has engendered a lot of unusual and conflicting practice models and outcome measures. We all owe a debt of gratitude to Dr. Charlie Cote and his AAP collaborators for reporting on sedation critical events and establishing the first standards for monitoring and general pediatric sedation practice parameters in 1985,3 but their application, and the optimization of this care, has been less than straightforward. In my own career, I transitioned in the early 1990’s from being a practicing pediatrician (who struggled to provide adequate sedation when needed for minor procedures and tests) – to a pediatric anesthesiologist with the ability to provide optimal sedation/anesthesia for any test or procedure, large of small. Looking back on my sedation attempts as a pediatrician, I was embarrassed and concerned about the care I had provided before my anesthesia training. I personally felt we had an obligation to improve sedation practice to every extent possible.
It was with this background that Dr. George Blike and I first organized the Pediatric Sedation Research Consortium (PSRC) in 2000. The idea was to bring together a multi-specialty group of sedation providers to compare practice models and results, particularly adverse events. We wanted to do this outside the purview of the any specialty society (ASA, AAP, or the American College of Emergency Physicians or the American Academy of Pediatric Dentists) because we wanted to avoid the inevitable political issues/battles that would be raised around the parameters of care, drugs employed etc. We recruited membership in the PSRC through a email newsletter we were writing at the time, and gathered 35 institutions who agreed to work on a standardized, prospective, data collection strategy and a regular series of meetings. Multiple group meetings and over 20 hours were spent defining the outcome measures of interest – including how to codify interventions made to prevent or rescue patients from undesirable physiological states. Our primary aim was to provide information on the practice of pediatric sedation, regardless of who, where, and how it was provided. The database was organized and run through the Dartmouth College Informatics group that had experience with multi-institutional outcome collaboratives.
The first paper from the PSRC was published in in 20061 (21 papers and counting have followed, a partial list can be found in the references).4-10 In today’s PAAD I am reviewing the original data from that article. Data was collected on 30,037 sedation encounters. Sedation providers involved included about 1/3 Critical Care Specialists, 1/3 Emergency Medicine, and 1/3 Anesthesiologists along with a small group of hospitalists (that segment has since grown significantly since then). Importantly, almost all of the cases were performed in the context of sedation services, not random, isolated episodes of sedation provided by various providers.
With all of this in mind, we reported a low rate of serious adverse events including just one true code event with chest compressions and code medications attributed to sedation practice. Hypoxia occurred 157 times and stridor/laryngospasm was reported 4.3/10,000 sedations. Unexpected apnea, excessive secretions, and vomiting had frequencies of 24, 41.6, and 47.2 per 10k sedation encounters. Just as important for reporting purposes was the collection of a description of the interventions that were required to rescue patients – including intubation, airway insertion, and bag-mask ventilation at 9.7, 27.6, and 63.9 per 10K sedations. In all an intervention was required in 1 out of 89 encounters.
In our conclusions we emphasized that our data were imperfect at best, and difficult to use for comparative analysis - given the many variables that were different across participating centers. On the other hand, we felt the report was valuable as the first prospective analysis of this practice with an actual incidence of events – previously we were dealing with case reports or case series which did not allow such a calculation. Perhaps most valuable was the ability to define the interventions or “critical competencies” that were required to keep patients safe or rescue from potential serious adverse events. We still feel that data-driven competency training is a huge step forward from the opinion-based competency formulation for various sedation levels that preceded our work.
Our subsequent papers have evaluated a huge variety of sedation controversies including the use of propofol by non-anesthesiologists,4 NPO status and adverse respiratory events, the influence of obesity on sedation outcomes, the impact of URI’s on sedation events7 and several others. The PSRC project continues and investigators are still using the database for sedation-related studies. The work of the PSRC led to the creation of the Society for Pediatric Sedation which is going strong at this time.
Ultimately the PSRC and our studies have been aimed at complementing the work of others (such as Dr. Cote) to further the understanding of sedation practice and, ultimately, make it safer and more effective for children around the world. I would invite anyone who is interested to join in the project and continue the collaborative, anesthesia-driven, improvement in this area of practice.
Send your thoughts and comments to Myron who will post them in a Friday reader response.
References
1. Cravero JP, Blike GT, Beach M, Gallagher SM, Hertzog JH, Havidich JE, Gelman B: Incidence and nature of adverse events during pediatric sedation/anesthesia for procedures outside the operating room: report from the Pediatric Sedation Research Consortium. Pediatrics. 2006; 118: 1087-1096
2. Yaster M, Cravero JP: The continuing conundrum of sedation for painful and nonpainful procedures. J.Pediatr. 2004; 145: 10-12
3. Guidelines for the elective use of conscious sedation, deep sedation, and general anesthesia in pediatric patients. Committee on Drugs. Section on anesthesiology, 76 edition, 1985
4. Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH: The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg 2009; 108: 795-804
5. Tsze DS, Mallory MD, Cravero JP: Practice Patterns and Adverse Events of Nitrous Oxide Sedation and Analgesia: A Report from the Pediatric Sedation Research Consortium. J Pediatr 2016; 169: 260-5.e2
6. Grunwell JR, Travers C, Stormorken AG, Scherrer PD, Chumpitazi CE, Stockwell JA, Roback MG, Cravero J, Kamat PP: Pediatric Procedural Sedation Using the Combination of Ketamine and Propofol Outside of the Emergency Department: A Report From the Pediatric Sedation Research Consortium. Pediatr Crit Care Med 2017; 18: e356-e363
7. Mallory MD, Travers C, McCracken CE, Hertzog J, Cravero JP: Upper Respiratory Infections and Airway Adverse Events in Pediatric Procedural Sedation. Pediatrics 2017; 140
8. Williams MR, Ward DS, Carlson D, Cravero J, Dexter F, Lightdale JR, Mason KP, Miner J, Vargo JJ, Berkenbosch JW, Clark RM, Constant I, Dionne R, Dworkin RH, Gozal D, Grayzel D, Irwin MG, Lerman J, O'Connor RE, Pandharipande P, Rappaport BA, Riker RR, Tobin JR, Turk DC, Twersky RS, Sessler DI: 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. Anesth Analg 2017; 124: 821-830
9. Ward DS, Williams MR, Berkenbosch JW, Bhatt M, Carlson D, Chappell P, Clark RM, Constant I, Conway A, Cravero J, Dahan A, Dexter F, Dionne R, Dworkin RH, Gan TJ, Gozal D, Green S, Irwin MG, Karan S, Kochman M, Lerman J, Lightdale JR, Litman RS, Mason KP, Miner J, O'Connor RE, Pandharipande P, Riker RR, Roback MG, Sessler DI, Sexton A, Tobin JR, Turk DC, Twersky RS, Urman RD, Weiss M, Wunsch H, Zhao-Wong A: Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations. Anesth Analg 2018; 127: 1146-1154
10. Cosgrove P, Krauss BS, Cravero JP, Fleegler EW: Predictors of Laryngospasm During 276,832 Episodes of Pediatric Procedural Sedation. Ann Emerg Med 2022; 80: 485-496