Haloperidol vs. Valproate in Agitation

Shahid Beheshti University of Medical Sciences56 enrolled

Overview

The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Psychomotor Agitation

Interventions

HaloperidolDRUG

ValproateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of psychomotor agitation * aged 18 to 65 years Exclusion Criteria: * Pregnant patients * Severe liver disease * History of drug (haloperidol/valproate) allergy * Readily amendable causes for the agitation (hypoxemia or hypoglycemia) * Hypotension (systolic blood pressure (SBP) ≤ 90 mm Hg) * Known history of liver disease or uncontrolled diabetes * Noticeable or suspected head trauma * Previous history of neuroleptic malignant syndrome * Receiving psychotropic medication, neuroleptic agents or cholinesterase inhibitors at the time of enrollment

Locations (1)

Department of Emergency Medicine, Imam Hossein Hospital

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Reduction in Agitated Behavior Scale (ABS) score

Patients were rated before medication administration and within 30 minutes afterwards according to Agitated Behavior Scale (ABS) score. Any statistically significant change in ABS score consider as positive effect of either intervention.

Time frame: within the first 30 minutes of treatment onset

Data from ClinicalTrials.gov

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