Metoclopramide for Acute Migraine: A Dose Finding Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- Pain Intensity Score
研究概览
简要总结
Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.
详细描述
Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute migraine
排除标准
- •secondary cause of headache
- •lumbar puncture
- •allergy or intolerance to study medication
研究组 & 干预措施
1
Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
干预措施: metoclopramide (Drug)
1
Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes
干预措施: Diphenhydramine 25mg (Drug)
2
metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
干预措施: metoclopramide (Drug)
2
metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.
干预措施: Diphenhydramine 25mg (Drug)
3
metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
干预措施: metoclopramide (Drug)
3
metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
干预措施: Diphenhydramine 25mg (Drug)
结局指标
主要结局
Pain Intensity Score
时间窗: Baseline, 60 minutes
Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.
次要结局
未报告次要终点
研究者
Benjamin W. Friedman, MD
Associate professor
Montefiore Medical Center