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Risk Factors for Adverse Events in Emergency Department Procedural Sedation for Children
Maala Bhatt1, David W Johnson2,3,4,5, Jason Chan6
1Department of Pediatrics, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.
Insights
Ketamine alone is the safest sedation for children in emergency departments, showing fewer serious adverse events (SAEs) and interventions. Other medications like propofol or fentanyl combined with ketamine increase risks for pediatric procedural sedation.
Area of Science:
- Pediatric Emergency Medicine
- Clinical Pharmacology
- Patient Safety
Background:
- Procedural sedation is standard in pediatric emergency departments for painful procedures.
- Previous studies on emergency department sedation have been limited by single-center designs and insufficient power to identify risk factors for serious adverse events (SAEs).
- This limitation hinders the ability to optimize sedation practices and improve patient outcomes.
Purpose of the Study:
- To determine the incidence of sedation-related SAEs in children undergoing procedures in emergency departments.
- To identify risk factors associated with these SAEs, particularly focusing on the type of sedation medication used.
Main Methods:
- A prospective, multicenter, observational cohort study was conducted across 6 Canadian pediatric emergency departments from 2010 to 2015.
- The study enrolled 6760 children (18 years or younger) who received sedation for painful procedures.
- Data collected included demographic characteristics, preprocedural factors, health risks, procedure type, and sedation medication, alongside outcomes like SAEs, significant interventions, oxygen desaturation, and vomiting.
Main Results:
- Of 6295 children analyzed, 11.7% experienced adverse events, with oxygen desaturation (5.6%) and vomiting (5.2%) being most common.
- Serious adverse events (SAEs) occurred in 1.1% of patients, and 1.4% required significant interventions.
- Ketamine hydrochloride alone was associated with the lowest incidence of SAEs (0.4%) and significant interventions (0.9%). Propofol alone, and combinations of ketamine with propofol or fentanyl, showed significantly higher rates of SAEs and interventions compared to ketamine alone.
Conclusions:
- The incidence of adverse sedation outcomes significantly varies based on the type of medication used.
- Ketamine monotherapy is associated with the best safety profile, demonstrating fewer SAEs and interventions compared to its combinations with propofol or fentanyl.
- These findings underscore the importance of medication choice in pediatric procedural sedation to minimize adverse events in emergency settings.
Importance:
Procedural sedation for children undergoing painful procedures is standard practice in emergency departments worldwide. Previous studies of emergency department sedation are limited by their single-center design and are underpowered to identify risk factors for serious adverse events (SAEs), thereby limiting their influence on sedation practice and patient outcomes.
Objective:
To examine the incidence and risk factors associated with sedation-related SAEs.
Design, Setting, And Participants:
This prospective, multicenter, observational cohort study was conducted in 6 pediatric emergency departments in Canada between July 10, 2010, and February 28, 2015. Children 18 years or younger who received sedation for a painful emergency department procedure were enrolled in the study. Of the 9657 patients eligible for inclusion, 6760 (70.0%) were enrolled and 6295 (65.1%) were included in the final analysis.
Exposures:
The primary risk factor was receipt of sedation medication. The secondary risk factors were demographic characteristics, preprocedural medications and fasting status, current or underlying health risks, and procedure type.
Main Outcomes And Measures:
Four outcomes were examined: SAEs, significant interventions performed in response to an adverse event, oxygen desaturation, and vomiting.
Results:
Of the 6295 children included in this study, 4190 (66.6%) were male and the mean (SD) age was 8.0 (4.6) years. Adverse events occurred in 736 patients (11.7%; 95% CI, 6.4%-16.9%). Oxygen desaturation (353 patients [5.6%]) and vomiting (328 [5.2%]) were the most common of these adverse events. There were 69 SAEs (1.1%; 95% CI, 0.5%-1.7%), and 86 patients (1.4%; 95% CI, 0.7%-2.1%) had a significant intervention. Use of ketamine hydrochloride alone resulted in the lowest incidence of SAEs (17 [0.4%]) and significant interventions (37 [0.9%]). The incidence of adverse sedation outcomes varied significantly with the type of sedation medication. Compared with ketamine alone, propofol alone (3.7%; odds ratio [OR], 5.6; 95% CI, 2.3-13.1) and the combinations of ketamine and fentanyl citrate (3.2%; OR, 6.5; 95% CI, 2.5-15.2) and ketamine and propofol (2.1%; OR, 4.4; 95% CI, 2.3-8.7) had the highest incidence of SAEs. The combinations of ketamine and fentanyl (4.1%; OR, 4.0; 95% CI, 1.8-8.1) and ketamine and propofol (2.5%; OR, 2.2; 95% CI, 1.2-3.8) had the highest incidence of significant interventions.
Conclusions And Relevance:
The incidence of adverse sedation outcomes varied significantly with type of sedation medication. Use of ketamine only was associated with the best outcomes, resulting in significantly fewer SAEs and interventions than ketamine combined with propofol or fentanyl.
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