Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The difference between pain scores for both drugs
研究概览
简要总结
Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.
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
- Double (Participant, Care Provider)
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
- •Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
- •The patients older than 18 years
- •Patients who agree to participate to the study by reading and signing the informed consent document
排除标准
- •The patients younger than 18 years
- •Pregnants
- •Patients taking any analgesic drugs last 2 hours
- •Documented or declared allergy to metoclopramide
- •Patients who are hemodynamically unstable
- •Patients who do not agree to participate to the study
研究组 & 干预措施
Intravenous metoclopramide
Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)
干预措施: Metoclopramide 10 mg (Drug)
Intravenous metoclopramide
Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)
干预措施: Placebo (Drug)
Intravenous metoclopramide
Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)
干预措施: Fentanyl (Drug)
Placebo
0.9% normal saline solution (total 100 mL)
干预措施: Metoclopramide 10 mg (Drug)
Placebo
0.9% normal saline solution (total 100 mL)
干预措施: Placebo (Drug)
Placebo
0.9% normal saline solution (total 100 mL)
干预措施: Fentanyl (Drug)
结局指标
主要结局
The difference between pain scores for both drugs
时间窗: 15th and 30th minutes
The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups
次要结局
- Adverse reactions(30th minute)
- Nausea and vomiting(30th minute)
- Need for rescue analgesic(30th minute)
- Change in the headache intensity(Between 24th and 72th hours)
- Duplicative presentation to the emergency department(Between 24th and 72th hours)
研究者
Nurettin Özgür Doğan
M.D., Associate Professor
Kocaeli University