A Randomized Placebo Controlled Trial of IV Metoclopramide for Acute Post-traumatic Headache
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
研究概览
简要总结
Nearly 1.5 million patients present to US emergency departments annually following head trauma. Headache is a frequent symptom of victims of head trauma. The purpose of this study is to see if an intravenous medication called metoclopramide can improve the symptoms of patients with acute post-traumatic headache.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Included patients will be adults who meet International Classification of Headache Disorders criteria for acute post-traumatic headache. These are as follows:
- •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.
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 MAO inhibitors, and use of anti-rejection transplant medications.
研究组 & 干预措施
Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
干预措施: Metoclopramide (Drug)
Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
干预措施: Diphenhydramine (Drug)
Metoclopramide
Metoclopramide 20mg + diphenhydramine 25mg + 100cc normal saline, administered as an intravenous drip
干预措施: Normal saline (Drug)
Placebo
Normal saline, administered as an intravenous drip
干预措施: Normal saline (Drug)
结局指标
主要结局
0-10 Pain Scale on Which 0 = no Pain and 10= the Worst Pain Imaginable
时间窗: 1 hour after medication administration
Improvement in this 0 to 10 verbal rating scale
次要结局
- Sustained Headache Relief(48 hours after medication administration)
- Headache Days(7 days after ED visit)
研究者
Benjamin W. Friedman, MD
Associate Professor
Montefiore Medical Center