Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
Overview
- Phase
- Phase 3
- Intervention
- metoclopramide
- Conditions
- Migraine
- Sponsor
- IRCCS Burlo Garofolo
- Locations
- 1
- Primary Endpoint
- evaluation of healing times from pain in the 3 groups
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Children 6-17 years old with migraine presenting in emergency room
Exclusion Criteria
- •Informed consensus not obtained
- •Occurring migraine still treated
- •Hemiplegic migraine
Arms & Interventions
1
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
Intervention: metoclopramide
1
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
Intervention: ketoprofen
2
metoclopramide 0,15 mg/Kg + placebo per os
Intervention: metoclopramide
2
metoclopramide 0,15 mg/Kg + placebo per os
Intervention: placebo
3
ketoprofen 1 mg/Kg and placebo in single dose
Intervention: placebo
3
ketoprofen 1 mg/Kg and placebo in single dose
Intervention: ketoprofen
Outcomes
Primary Outcomes
evaluation of healing times from pain in the 3 groups
Time Frame: 2 hours
Secondary Outcomes
- 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)