Haloperidol versus Ketamine for Managing Acute Agitation in the Emergency Department: A Randomized Clinical Trial.
Sayyed Majid Sadrzadeh, Ala Montazeri, Behrang Rezvani Kakhki, Elnaz Vafadar Moradi
Bulletin of emergency and trauma 2025 DOI: 10.30476/beat.2025.106204.1583 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized clinical trial Peer reviewed |
|---|---|
| Sample size | 120 |
| Population | Adults aged 18 to 65 with acute agitation requiring pharmacological intervention at two hospitals in Mashhad, Iran |
| Interventions | Haloperidol Ketamine |
| Dose | 5 mg of intravenous haloperidol or 2 mg/Kg of intravenous ketamine |
| Topics | Ketamine Esketamine |
| Keywords | Emergence delirium Psychomotor agitation Emergency medicine Agitation management Ketamine vs haloperidol |
| Key findings | Ketamine had a faster onset of action than haloperidol for managing acute agitation. |
Abstract
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. 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). 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. 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.
Comparable studies
Other randomized controlled trials on ketamine, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Subanesthetic Effects of the Noncompetitive NMDA Antagonist, Ketamine, in Humans Healthy human subjects recruited from the community | 1994 | Randomized controlled trial | n = 19 |
| Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial Patients with treatment-resistant major depression experiencing a major depressive episode | 2013 | Randomized controlled trial | n = 73 |
| Remifentanil-induced Postoperative Hyperalgesia and Its Prevention with Small-dose Ketamine Patients undergoing major abdominal surgery | 2005 | Randomized controlled trial | n = 75 |
| Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures | 2014 | Randomized controlled trial | n = 41 |
| Ketamine-Induced Deficits in Auditory and Visual Context-Dependent Processing in Healthy Volunteers Healthy volunteers | 2000 | Single-blind placebo-controlled study | n = 20 |