Corticosteroids for Acute Migraine. An ED-based, Randomized, Comparative Effectiveness Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Headache Days as Self-reported by Participants
研究概览
简要总结
This is an emergency department based randomized trial in which we compare two different treatment for migraine headache. The goal is to decrease the number of headache days during the week after ED discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Migraine without aura criteria (International Classification of Headache Disorders 3B )
- •Headache rated as moderate or severe in intensity
排除标准
- •Concern for secondary cause of headache
- •Contra-indications to investigational medications
研究组 & 干预措施
Control
Metoclopramide 10mg IV+ dexamethasone 10mg IM
干预措施: metoclopramide (Drug)
Control
Metoclopramide 10mg IV+ dexamethasone 10mg IM
干预措施: Dexamethasone (Drug)
Experimental
Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
干预措施: metoclopramide (Drug)
Experimental
Metoclopramide 10mg IV + methylprednisolone acetate 160mg IM
干预措施: methylprednisolone acetate (Drug)
结局指标
主要结局
Headache Days as Self-reported by Participants
时间窗: 7 days after discharge from emergency department
At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.
次要结局
- Number of Participants With Sustained Headache Freedom(7 days after discharge from emergency department)
- Medication Preference as Assessed by Self-report(7 days after discharge from emergency department)
研究者
Benjamin W. Friedman, MD
PI
Montefiore Medical Center