Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- evaluation of healing times from pain in the 3 groups
研究概览
简要总结
This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:
- metoclopramide 0,15 mg/kg + placebo
- metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg
- ketoprofen 1 mg/Kg + placebo
Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min.
The main objective is the evaluation of healing times from pain in the 3 groups
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 6-17 years old with migraine presenting in emergency room
排除标准
- •Informed consensus not obtained
- •Occurring migraine still treated
- •Hemiplegic migraine
研究组 & 干预措施
1
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
干预措施: metoclopramide (Drug)
1
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
干预措施: ketoprofen (Drug)
2
metoclopramide 0,15 mg/Kg + placebo per os
干预措施: metoclopramide (Drug)
2
metoclopramide 0,15 mg/Kg + placebo per os
干预措施: placebo (Drug)
3
ketoprofen 1 mg/Kg and placebo in single dose
干预措施: placebo (Drug)
3
ketoprofen 1 mg/Kg and placebo in single dose
干预措施: ketoprofen (Drug)
结局指标
主要结局
evaluation of healing times from pain in the 3 groups
时间窗: 2 hours
次要结局
- need of a rescue drug for lack of effect in every arms of the trial(2 hours and 24 hours for relapses)
- comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial(2 and 24 hours respectively)