Midazolam-Droperidol, Droperidol, or Olanzapine for Acute Agitation: A Randomized Clinical Trial - 19/04/17
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Abstract |
Study objective |
We aim to determine the most efficacious of 3 common medication regimens for the sedation of acutely agitated emergency department (ED) patients.
Methods |
We undertook a randomized, controlled, double-blind, triple-dummy, clinical trial in 2 metropolitan EDs between October 2014 and August 2015. Patients aged 18 to 65 years and requiring intravenous medication sedation for acute agitation were enrolled and randomized to an intravenous bolus of midazolam 5 mg–droperidol 5 mg, droperidol 10 mg, or olanzapine 10 mg. Two additional doses were administered, if required: midazolam 5 mg, droperidol 5 mg, or olanzapine 5 mg. The primary outcome was the proportion of patients adequately sedated at 10 minutes.
Results |
Three hundred forty-nine patients were randomized to the 3 groups. Baseline characteristics were similar across the groups. Ten minutes after the first dose, significantly more patients in the midazolam-droperidol group were adequately sedated compared with the droperidol and olanzapine groups: differences in proportions 25.0% (95% confidence interval [CI] 12.0% to 38.1%) and 25.4% (95% CI 12.7% to 38.3%), respectively. For times to sedation, the differences in medians between the midazolam-droperidol group and the droperidol and olanzapine groups were 6 (95% CI 3 to 8) and 6 (95% CI 3 to 7) minutes, respectively. Patients in the midazolam-droperidol group required fewer additional doses or alternative drugs to achieve adequate sedation. The 3 groups’ adverse event rates and lengths of stay did not differ.
Conclusion |
Midazolam-droperidol combination therapy is superior, in the doses studied, to either droperidol or olanzapine monotherapy for intravenous sedation of the acutely agitated ED patient.
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Please see page 319 for the Editor’s Capsule Summary of this article. |
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Supervising editor: Steven M. Green, MD |
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Author contributions: All authors conceived and designed the study, contributed to the ethics committee (institutional review board) application, contributed to interpretation of the results, drafted the article, and contributed to its revision. DMcDT obtained the research funding. CYLY, SET, and DCMK prepared the study packs. DMcDT and CYLY supervised the study overall. JCK, GAP, and JK supervised the study at their respective sites. CYLY, JCK, GAP, and JK were responsible for all staff education. CYLY managed collation of the data and entry into the study database. DMcDT, CYLY, and JCK undertook the data analysis. DMcDT takes responsibility for the paper as a whole. |
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Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). The authors have stated that no such relationships exist. The study was supported by the Morson Taylor Research Award 2013 of the Australasian College for Emergency Medicine Foundation and the Austin Health Medical Research Foundation, 2014. |
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Trial registration number: ACTRN12607000591459 |
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Neither of the funding organizations had any role in the design or execution of the study, or the data analysis or interpretation. |
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Vol 69 - N° 3
P. 318 - mars 2017 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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