Metoclopramide for Post-Traumatic Headache. A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants With Sustained Headache Relief
研究概览
简要总结
Post-traumatic headache is common. We are determining short and longer-term outcomes among patients treated for post-traumatic headache with IV metoclopramide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Traumatic injury to the head has occurred
- •Headache has developed within 7 days of injury to the head
- •Headache is not better accounted for by another diagnosis (eg, previous history of migraine or tension-type headache)
- •The headache must be rated as moderate or severe in intensity at the time of initial evaluation.
- •The plan of the attending emergency physician must include treatment with parenteral metoclopramide.
排除标准
- •Patients will be excluded if more than ten days have elapsed since the head trauma, if the headache has already been treated with an anti-dopaminergic medication, or for medication contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of monoamine oxidase inhibitors, and use of anti-rejection transplant medications. Patients will not be excluded for pregnancy or breast-feeding.
研究组 & 干预措施
Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
干预措施: Diphenhydramine (Drug)
Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg administered intravenously over 15 minutes
干预措施: Metoclopramide (Drug)
结局指标
主要结局
Number of Participants With Sustained Headache Relief
时间窗: 2 hours thru 48 hours after treatment
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. 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 Satisfied With Medication; Assessed by Self-evaluation(48 hours after treatment)
- Post Concussion Symptoms Assessed by Post-concussive Symptom Scale(7 days)
研究者
Benjamin W. Friedman, MD
Professor
Montefiore Medical Center