Olanzapine vs Haloperidol for Management of Acute Agitation in Emergency Department: An Open Label Randomized Controlled Trial

Abstract

Background: Acute agitation is a common presentation in the emergency department (ED), often managed with haloperidol. This study aimed to compare the efficacy and safety of olanzapine versus haloperidol for the initial treatment of acute agitation in the ED.

Objectives: Primary outcome was adequate sedation at 15 minutes, defined as Altered Mental Status (AMS) score of zero or less. Secondary outcomes included adequate sedation at 30 minutes, need for rescue medications and reported adverse events.

Methods: This open-label, randomized controlled trial included adult patients presenting to the ED with acute agitation, defined with an AMS score ≥ 3. After taking surrogate consent from their legally authorized representative, patients were randomly assigned to receive either intramuscular (IM) olanzapine (10 mg) or IM haloperidol (5 mg).

Results: Of the total 94 patients, 47 received IM olanzapine and 47 received IM haloperidol. Similar proportions of patients were adequately sedated at 15 min (olanzapine 31.9% vs haloperidol 25.5%; relative risk [RR] - 1.25, 95% confidence interval [CI] 0.65 to 2.37; p - 0.494) and 30 min (olanzapine 61.7% vs haloperidol 48.9%; RR - 1.26, 95% CI 0.87 to 1.82; p - 0.213). The need for rescue medications was similar (olanzapine 12.7% vs. haloperidol 25.5%; RR 0.5, 95% CI 0.20 to 1.22; p 0.116). Adverse events were uncommon and similar across both arms (olanzapine 4.2% vs. haloperidol 10.6%; RR 0.4, 95% CI 0.08 to 1.96; p 0.238).

Conclusion: Intramuscular olanzapine performed better than IM haloperidol in the management of acute agitation in ED. However, the differences were not statistically significant.

Keywords: agitation; efficacy; emergency; haloperidol; olanzapine; safety.