Haloperidol vs. Valproate in Agitation
- Registration Number
- NCT01750541
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Haloperidol Haloperidol Haloperidol 5mg intramuscular injection Valproate Valproate Valproate single Infusion; 400 mg (weigh\<60 kg), 500 mg (weight\>60 Kg)
- Primary Outcome Measures
Name Time Method Reduction in Agitated Behavior Scale (ABS) score within the first 30 minutes of treatment onset 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Emergency Medicine, Imam Hossein Hospital
🇮🇷Tehran, Iran, Islamic Republic of