NCT02747511已完成4 期
Intravenous Haloperidol for the Treatment of Headache in the Emergency Department
Western Michigan University School of Medicine0 个研究点目标入组 118 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 主要终点
- >50% reduction in pain per Visual Analog Scale (VAS)
研究概览
简要总结
Single center, double-blind, randomized, placebo-controlled trial evaluating analog pain scores in patients who present to the emergency department (ED) with a complaint of headache. A total of 150 patients age 13-55 presenting to the emergency department with headache will be enrolled from October 2015 - October 2016. Patients will be randomized and pain scores and side effects will be recorded at 0, 30, 60, and 90 minutes. Follow-up will be performed by telephone at 24 hours.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 13 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Emergency Department patients that complain of headache or migraine
- •Males and females age 13-55
- •English is primary language
排除标准
- •Abnormal blood pressure (>200/100)
- •Sudden rapid onsent (normal to worst pain in minutes)
- •Any history of masses, strokes, head injury or other causes of abnormal anatomy
- •QT greater than 450 ms on EKG
- •Allergy to Haldon
- •Any altered mental status (GCS <15)
- •Pregnancy
- •Any abnormalities on neurologic exam
- •Any clinician concern that would require CT scan of brain
- •Any prisoner or ward of state
研究组 & 干预措施
Haloperidol
Active Comparator
干预措施: Haloperidol (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
>50% reduction in pain per Visual Analog Scale (VAS)
时间窗: 90 minute interval
次要结局
未报告次要终点
研究者
Jessica McCoy
Clinical Associate Professor
Western Michigan University School of Medicine
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