Etomidate Versus Midazolam for Procedural Sedation in Pediatric Outpatients: A Randomized Controlled Trial
Presented at the Society for Pediatric Research annual meeting, May 2005, Washington, DC; Society of Academic Emergency Medicine annual meeting, May 2005, New York, NY; Canadian Association of Emergency Physicians annual meeting May 2005, Edmonton, Alberta, Canada; and the Canadian Pediatric Society, June 2005, Vancouver, British Columbia, Canada.
Received 30 November 2005; received in revised form 14 February 2006; accepted 22 February 2006. published online 26 April 2006.
Study objective
Midazolam is widely used for procedural sedation and analgesia. Etomidate has been studied mostly in adults. Our objective is to compare the efficacy of etomidate and midazolam for achieving procedural sedation and analgesia in children.
Methods
A randomized, double-blind, emergency department and orthopedic clinic-based trial was carried out among patients aged 2 to 18 years with displaced extremity fractures. Patients were administered 1 μg/kg of fentanyl and either 0.2 mg/kg of etomidate or 0.1 mg/kg of midazolam. Adequate sedation was defined, for the purpose of this study, as a score of 4 or more on the Ramsay Sedation Scale. The primary outcome was induction and recovery time. The rates of adverse events, success of fracture reduction, and parent and physician satisfaction were also compared.
Results
From April to August 2004, 100 of 128 eligible patients were enrolled (age 8.7±3.7 years; 50% male patients). A higher proportion of patients attained adequate sedation among those who received etomidate: 46 of 50 (92%) versus 18 of 50 (36%) (Δ 56%; 95% confidence interval [CI] 38% to 69%). Time taken for induction (hazard ratio 4.9; 95% CI 2.2 to 10.9) and time taken for recovery (hazard ratio 2.8; 95% CI 1.5 to 5.1) were lower among patients who received etomidate. The rates of adverse events were similar in both groups, except for myoclonus and pain at the injection site, which was more frequent in the etomidate group.
Conclusion
Induction and recovery times are shorter with etomidate compared with midazolam. At the dosages used for procedural sedation and analgesia among children with displaced extremity fracture, etomidate has higher efficacy in comparison with midazolam.
aDivision of Emergency Medicine, Department of Pediatrics, Centre Hospitalier Universitaire Ste-Justine, Montréal, Quebec, Canada
bDepartment of Pharmacy, Centre Hospitalier Universitaire Ste-Justine, Montréal, Quebec, Canada
cResearch Center, Centre Hospitalier Universitaire Ste-Justine, Montréal, Quebec, Canada
dDivision of Clinical Pharmacology, Department of Pediatrics, and Division of Orthopedics, Department of Surgery, Centre Hospitalier Universitaire Ste-Justine, Montréal, Quebec, Canada
eDivision of Orthopedics, Department of Surgery, Centre Hospitalier Universitaire Ste-Justine, Montréal, Quebec, Canada
Address for correspondence: Lydia Di Liddo, MD, Department of Pediatrics, Centre Hospitalier Universitaire Ste-Justine, 3175 Chemin de la Côte Ste-Catherine, Montréal, Quebec H3T 1C5, Canada; 514-345-4788, fax 514-345-4965
Supervising editor: Steven M. Green, MD
Author contributions: LD, AD, BN, BB, DA, and CS conceived the study, designed the trial, and obtained research funds. LD was responsible for the conduct of the trial, patient recruitment, and data collection. BB and DA provided statistical advice on study design and analyzed the data. LD drafted the manuscript and all authors contributed to its revision. LD takes the responsibility for the paper as a whole.
Funding and support: This study was supported by a grant from Fonds d’opération pour les projets de recherche de l’Hôpital Ste-Justine.
ABSTRACT