Clinical Trial: Haloperidol vs. Valproate in Agitation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome: 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.


Original Primary Outcome: Reduction in aggression and agitation [ Time Frame: within the first 4 hour of treatment onset ]

Patients were rated at each assessment point on whether they were tranquil or asleep and get improvement in overall agitation scale score. Participants were considered to be tranquil when they were calm and not exhibiting agitated, aggressive or dangerous behavior.

They were considered to be asleep if, they appeared to be sound asleep on inspection and were not aroused by ambient disturbances.



Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: December 7, 2012
Date Started: December 2012
Date Completion:
Last Updated: January 5, 2013
Last Verified: January 2013