Psychomotor Agitation Clinical Trial
Official title:
Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
Verified date | January 2013 |
Source | Shahid Beheshti University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department
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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Department of Emergency Medicine, Imam Hossein Hospital | Tehran |
Lead Sponsor | Collaborator |
---|---|
Shahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
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 |
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