MedicalResearch.com Interview with:
Maala Bhatt MD, MSc., FRCPC
Director, Pediatric Emergency Research
Staff Physician, Emergency Medicine
Children’s Hospital of Eastern Ontario
MedicalResearch.com: What is the background for this study?
Response: Procedural sedation, defined as the administration of medications to minimize pain and awareness, has become standard practice in pediatric emergency departments worldwide to facilitate short, painful procedures such as orthopedic reduction and complex laceration repairs. Although emergency department sedation is regarded as safe, serious adverse events have been reported. The incidence of these events has been difficult to determine due to the infrequency of their occurrence and lack of large, multi-center surveillance studies focused on systematic detection of adverse events. Previous studies of emergency department sedation have been limited by single-center design and small sample sizes. These studies have not been able to reliably predict sedation-related adverse events, their severity or impact on patients.
To improve understanding of the safety and comparative effectiveness of ED procedural sedation, we conducted a large multi-center cohort study using standardized outcome measures that are valid and relevant to clinical practice. Our primary objective was to determine which practices lead to the best outcomes in children undergoing emergency department procedural sedation.
MedicalResearch.com: What are the main findings?
Response: We enrolled 6,295 patients undergoing parenteral procedural sedation for a painful procedure in one of six Canadian pediatric emergency departments from July 2010 to February 2015.
The overall incidence of adverse events in our population was 11.7%. Oxygen desaturation (5.6%) and vomiting (5.2%) were the most common events. Serious adverse events and significant interventions in response to an adverse event were rare occurring in only 1.1% and 1.4% of patients respectively.
We found that choice of sedation medication had the biggest impact on the incidence of adverse events and need for significant interventions in response to those events. The incidence of serious adverse events and significant interventions was lowest among patients sedated with ketamine-alone and highest among patients sedated with combination drugs ketamine+propofol and ketamine+fentanyl. We also found that pre-procedural opioid administration was strongly associated with increased odds of oxygen desaturation, vomiting and need for significant interventions, regardless of sedation medication.
Higher doses of ketamine were associated with increased odds of oxygen desaturation and vomiting. These findings are in opposition to the common belief that ketamine does not exhibit a dose-response relationship.
We also found that pre-procedural anti-emetics were associated with a 50% reduction in the odds of vomiting. However, based on published evidence, use in children under five years may not be as advantageous as their baseline risk is much lower.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: Procedural sedation for children provided by Emergency Physicians in these tertiary care pediatric emergency departments is safe and effective with low rates of serious adverse events (1.1%) and significant interventions (1.4%). Ketamine, Ketamine and Propofol and Propofol alone are all effective and safe in the hands of competent/experienced providers, however using ketamine alone is associated with fewer serious adverse events and significant interventions.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Our finding that administering opioids prior to sedation increases the odds of oxygen desaturation, vomiting and the need for significant interventions is interesting. Future work could focus on the timing of opioid administration and the incidence of adverse events. We are also interesting in understanding the longer term effects of sedation medications, controlling for age.
Disclosures: This study was supported by a Canadian Institutes of Health Research Team Grant in Pediatric Emergency Medicine.
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Bhatt M, Johnson DW, Chan J, Taljaard M, Barrowman N, Farion KJ, Ali S, Beno S, Dixon A, McTimoney CM, Dubrovsky AS, Sourial N, Roback MG, for the Sedation Safety Study Group of Pediatric Emergency Research Canada (PERC). Risk Factors for Adverse Events in Emergency Department Procedural Sedation for Children. JAMA Pediatr. Published online August 21, 2017. doi:10.1001/jamapediatrics.2017.2135
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