Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- One hour pain scores
研究概览
简要总结
Migraine headaches are a common reason for patients to present to an emergency department. We are comparing two different medications to see which one is better for patients who present ot an emergency room with a migraine headache.
详细描述
One-third of the five million headache patients who present to US Emergency Departments (ED) annually have a migraine headache. The anti-emetic dopamine receptor antagonists have proven efficacy for migraines, are at least as well-tolerated as triptans, and enjoy wide-spread use in North American EDs. However, it is not yet clear which medication within this class and which dosage is optimal. Therefore, we propose a randomized clinical trial to compare the efficacy and tolerability of two standard medications for migraine.
Specific Aim: To compare the efficacy of metoclopramide versus prochlorperazine for the emergency department treatment of migraine headaches. Both of these medications will be combined with diphenhydramine to prevent extra-pyramidal side effects.
Patients will be enrolled as participants if they present to one of the participating EDs and consent to participate. Medications will be administered as an intravenous drip over 15 minutes. Rescue medication will be administered, if needed, after one hour. A follow-up phone call will be conducted 24 hours after the ED visit.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to the Ed with an acute migraine headache
排除标准
- •secondary headache
- •if the patient is to receive a lumbar puncture in the ED
- •maximum temperature greater than 100.3 degrees
- •new objective neurologic abnormality at the time of physical exam
- •allergy or intolerance to a study medication
- •pregnancy
- •previous enrollment
结局指标
主要结局
One hour pain scores
次要结局
- One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.
研究者
Benjamin W. Friedman, MD
Prof. Emergency Medicine
Montefiore Medical Center