Pediatrics/original researchEtomidate Versus Midazolam for Procedural Sedation in Pediatric Outpatients: A Randomized Controlled Trial
Introduction
Painful procedures in the pediatric emergency department (ED) are frequent and the underuse of analgesia and sedation among children has been well documented.1 The ideal sedative agent for procedural sedation and analgesia would have a rapid onset of action and a brief half-life, therefore permitting easy titration on response and a rapid recovery time once the procedure is over. Also, it would induce amnesia and sedation and decrease muscular tone while having no adverse effects. Unfortunately, no single agent has all these properties. Midazolam, a benzodiazepine, is the most widely used intravenous sedative in the ED for adults, as well as children.2, 3, 4, 5 Although well accepted for procedural sedation and analgesia, its time of onset is relatively long, and the recovery time can be prolonged with high doses.3, 6 It also has the potential for inducing respiratory depression and hypotension.7 A drug that offers promise for procedural sedation and analgesia is etomidate. Its use has been initially described for rapid sequence intubation in the ED in adults, as well as in children.8, 9, 10 It offers a rapid onset of sedative effect, brief half-life, short recovery time, and minimal effect on the respiratory and cardiovascular systems.11
Balancing adequate procedural sedation and analgesia with rapid discharge after the procedure is a major challenge to emergency physicians. The use of etomidate would greatly reduce the time nurses and physicians have to stay at the patient’s bedside, ensuring a faster turnover without compromising patient safety. However, there is a paucity of literature that addresses the use of etomidate for procedural sedation and analgesia specifically in large samples of outpatient children.
The objective of this study was thus to compare the induction and recovery times of etomidate and midazolam in children presenting to the pediatric ED and orthopedics clinic with extremity fractures requiring procedural sedation and analgesia for reduction at a large tertiary-care facility.
Section snippets
Study Design
The study was a prospective, double-blind, randomized, controlled clinical trial. The ethical review board at our institution approved the study. Written informed consent was obtained from a parent for all children. All children able to understand the study also provided their verbal or written assent.
Setting and Selection of Participants
Patient enrollment took place in the ED department, as well as the orthopedic outpatient clinic, at a tertiary-care urban pediatric center with annual census of more than 60,000 visits to the ED
Results
During the study period (April 22, 2004, to August 23, 2004), 128 eligible children were identified for participation. Twenty-eight of these patients were not enrolled, because of refusal by parents, unavailability of the principal investigator, or a pneumomediastinum discovered on further evaluation (Figure 1). One hundred patients, 50 per group, were enrolled and were randomized. Baseline characteristics of the 2 groups were similar (Table 1).
In the etomidate group, 46 patients (92%) achieved
Limitations
A primary limitation of this study is the etomidate-associated myoclonus hindering reliable blinding for the study, which may have introduced bias.
Another limitation of the study was that only 36% of the patients in the midazolam group were able to reach an adequate level of sedation (Ramsay score ≥4). The patients who did not achieve adequate sedation underwent fracture reduction nonetheless but could not be used for further subanalysis for this outcome (using the nonparametric Cox
Discussion
The findings from this double-blind, randomized, controlled trial suggest that in children requiring procedural sedation and analgesia, the use of etomidate resulted in shorter induction and recovery times compared with midazolam. Similarly, we observed that in comparison to midazolam, etomidate adequately sedated a significantly greater proportion of patients. The success of fracture reduction was, however, similar for both groups.
Etomidate use had been initially described for rapid sequence
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Cited by (0)
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.
Reprints not available from the authors.