NCT01750541已完成3 期
Haloperidol vs. Valproate in the Management of Agitated Patients Presenting to the Emergency Department: A Randomized Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Reduction in Agitated Behavior Scale (ABS) score
研究概览
简要总结
The aim of this study is to compare the efficacy of haloperidol and valproate in management of people with agitation in emergency department
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of psychomotor agitation
- •aged 18 to 65 years
排除标准
- •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
研究组 & 干预措施
Valproate
Active Comparator
Valproate single Infusion; 400 mg (weigh<60 kg), 500 mg (weight>60 Kg)
干预措施: Valproate (Drug)
Haloperidol
Active Comparator
Haloperidol 5mg intramuscular injection
干预措施: Haloperidol (Drug)
结局指标
主要结局
Reduction in Agitated Behavior Scale (ABS) score
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Kamran Heydari
Assistant Professor of Emergency Medicine
Shahid Beheshti University of Medical Sciences
研究点 (1)
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