Haloperidol versus Ketamine for Managing Acute Agitation in the Emergency Department: A Randomized Clinical Trial.

Abstract

Objective: The primary outcome was the management of acute agitation, as measured by the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes included the incidence of adverse effects and the time to onset of the therapeutic effect.

Methods: This randomized clinical trial was conducted between March 2021 and March 2022. Participants were recruited from patients presenting with acute agitation who required pharmacological intervention at Emam Reza and Shahid Hasheminejad hospitals (Mashhad, Iran). Eligible participants were adults aged 18 to 65 years. Using a block randomization method with a block size of four, patients were assigned to receive either 5 mg of intravenous (IV) haloperidol or 2 mg/Kg of IV ketamine. Data were analyzed using SPSS software (version 22).

Results: A total of 120 participants were randomized. The majority were male, comprising 43 (73%) in the haloperidol group and 45 (75%) in the ketamine group. The mean age was 45.42±16.65 in the ketamine group and 48.28±16.75 years in the haloperidol group (p=0.34). In the haloperidol group, the mean admission RASS score was 1.73±0.75, which decreased to 0.07±1.25 post-intervention. In the ketamine group, the mean admission RASS score was 1.58±0.61, which improved to -0.92±1.19 following treatment.

Conclusion: Ketamine demonstrated a faster onset of action in managing acute agitation than haloperidol. These findings suggested that ketamine might represent a viable first-line therapeutic option for acutely agitated patients, particularly in clinical scenarios where rapid symptom control is critical.