Haloperidol vs. Valproate in Agitation

January 5, 2013 updated by: Dr. Kamran Heydari, Shahid Beheshti University of Medical Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1617763141
        • Department of Emergency Medicine, Imam Hossein Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Haloperidol
Haloperidol 5mg intramuscular injection
Drug: Haloperidol
Other Names:
  • Haldol
Active Comparator: Valproate
Valproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg)
Drug: Valproate
Other Names:
  • Depakene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Agitated Behavior Scale (ABS) score
Time Frame: 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.
within the first 30 minutes of treatment onset

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Kamran Heydari, MD, Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 7, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 5, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-021
  • MOH-021 (Other Identifier: The Ministry of Health and Medical Education (MOHME))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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