Haloperidol vs. Valproate in Agitation
Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
2 other identifiers
interventional
56
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 7, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJanuary 8, 2013
January 1, 2013
Same day
December 7, 2012
January 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Haloperidol
ACTIVE COMPARATORHaloperidol 5mg intramuscular injection
Valproate
ACTIVE COMPARATORValproate single Infusion; 400 mg (weigh\<60 kg), 500 mg (weight\>60 Kg)
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of psychomotor agitation
- aged 18 to 65 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Emergency Medicine, Imam Hossein Hospital
Tehran, Tehran Province, 1617763141, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamran Heydari, MD
Department of Emergency Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Emergency Medicine
Study Record Dates
First Submitted
December 7, 2012
First Posted
December 17, 2012
Study Start
December 1, 2012
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
January 8, 2013
Record last verified: 2013-01