Maala Bhatt1, David W Johnson2,3,4,5, Jason Chan6, Monica Taljaard7,8, Nick Barrowman6, Ken J Farion1, Samina Ali9, Suzanne Beno10, Andrew Dixon9, C Michelle McTimoney11,12, Alexander Sasha Dubrovsky13, Nadia Sourial6,14, Mark G Roback15,16. 1. Department of Pediatrics, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada. 2. Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 3. Department of Emergency Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 4. Departments of Physiology and Pharmacology, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 5. Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada. 6. Children's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada. 7. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada. 8. School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada. 9. Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada. 10. Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. 11. Department of Pediatrics, IWK Health Centre, Dalhousie University, Halifax, Nova Scotia, Canada. 12. Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada. 13. Department of Pediatrics, Montreal Children's Hospital, McGill University, Montreal, Quebec, Canada. 14. Department of Family Medicine, McGill University, Montreal, Quebec, Canada. 15. Department of Pediatrics, University of Minnesota Medical School, Minneapolis. 16. Department of Emergency Medicine, University of Minnesota Medical School, Minneapolis.
Abstract
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.
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.
Authors: Joseph P Cravero; George T Blike; Michael Beach; Susan M Gallagher; James H Hertzog; Jeana E Havidich; Barry Gelman Journal: Pediatrics Date: 2006-09 Impact factor: 7.124
Authors: Maala Bhatt; David W Johnson; Monica Taljaard; Jason Chan; Nick Barrowman; Ken J Farion; Samina Ali; Suzanne Beno; Andrew Dixon; C Michelle McTimoney; Alexander Sasha Dubrovsky; Mark G Roback Journal: JAMA Pediatr Date: 2018-07-01 Impact factor: 16.193