Elsevier

Annals of Emergency Medicine

Volume 48, Issue 4, October 2006, Pages 433-440.e1
Annals of Emergency Medicine

Pediatrics/original research
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.
https://doi.org/10.1016/j.annemergmed.2006.03.004Get rights and content

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.

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.

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