An RCT of Metoclopramide/Diphenhydramine vs. Ketorolac Alone for Tension-type Headache
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Change in Pain Score
研究概览
简要总结
Occasionally, episodic tension-type headache may be severe enough to require an emergency department (ED) visit. The purpose of this study is to compare two commonly used medications to see which is better for tension type headache. Patients who present to the ED with an acute tension-type headache requiring treatment with injectable medication will be randomized to metoclopramide or ketorolac.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute tension type headache
排除标准
- •Contraindications to investigational medications
- •Secondary cause of headache
研究组 & 干预措施
Ketorolac
Ketorolac 30mg IVSS
干预措施: Ketorolac (Drug)
Metoclopramide
metoclopramide 20mg IVSS + diphenhydramine 25mg IVSS
干预措施: Metoclopramide (Drug)
结局指标
主要结局
Change in Pain Score
时间窗: Baseline, 60 minutes
At baseline at at 60 minutes, all patients were asked to describe their pain on a scale from 0 to 10, with 0 representing no pain and 10 the worst imaginable. The primary outcome is the 60 minute score subtracted from the baseline score
次要结局
- Satisfaction Scores(24 hours)
研究者
Benjamin W. Friedman, MD
Associate professor
Montefiore Medical Center