Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
- Registration Number
- NCT00557544
- Lead Sponsor
- IRCCS Burlo Garofolo
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 ketoprofen ketoprofen 1 mg/Kg and placebo in single dose 2 metoclopramide metoclopramide 0,15 mg/Kg + placebo per os 2 placebo metoclopramide 0,15 mg/Kg + placebo per os 3 placebo ketoprofen 1 mg/Kg and placebo in single dose 1 ketoprofen metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose 1 metoclopramide metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
- Primary Outcome Measures
Name Time Method evaluation of healing times from pain in the 3 groups 2 hours
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Edoardo Guglia
🇮🇹Trieste, Italy