Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
研究概览
简要总结
Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Migraine headache (International Classification of Headache Disorders 3B criteria)
排除标准
- •Brain imaging ordered
- •Objective neurological findings
- •Pregnancy/ breast feeding
- •Allergy/ contraindication to investigational medication
- •History of addiction to opioids, use of methadone, any use of opioids previous 30 days
研究组 & 干预措施
Hydromorphone
Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.
干预措施: Hydromorphone (Drug)
Prochlorperazine
Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.
Patients can receive second 10mg dose at 1 hour.
干预措施: Prochlorperazine (Drug)
Prochlorperazine
Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.
Patients can receive second 10mg dose at 1 hour.
干预措施: Diphenhydramine (Drug)
结局指标
主要结局
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
时间窗: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours, without use of addition medication. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration.
次要结局
- Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire(48 hours after discharge from Emergency Department)
- Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire(48 hours after discharge from Emergency Department)
- Number of Participants Needing Rescue Medication as Assessed by Questionnaire(48 hours after discharge from Emergency Department)
研究者
Benjamin W. Friedman, MD
Associate Professor
Montefiore Medical Center