Haloperidol vs. Valproate in Agitation

Psychomotor Agitation Clinical Trial

Official title:

Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750541
• Other study ID #: SB-021
• Secondary ID: MOH-021
• Status: Completed
• Phase: Phase 3
• First received: December 7, 2012
• Last updated: January 5, 2013
• Start date: December 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychomotor Agitation

Intervention

Drug:
• Haloperidol

• Valproate

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Emergency Medicine, Imam Hossein Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within the first 30 minutes of treatment onset