Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
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...
Brief Summary
Official Title: “Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child”
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
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: December 2009
Intervention(s) in this Clinical Trial
- Drug: metoclopramide
- metoclopramide 0,15 mg/kg
- Drug: placebo
- placebo per os
- Drug: ketoprofen
- ketoprofen 1 mg/Kg
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
- Active Comparator: 2
- metoclopramide 0,15 mg/Kg + placebo per os
- Active Comparator: 3
- ketoprofen 1 mg/Kg and placebo in single dose
Outcome Measures for this Clinical Trial
Primary Measures
- evaluation of healing times from pain in the 3 groups
- Time Frame: 2 hours
Safety Issue?: Yes
- Time Frame: 2 hours
Secondary Measures
- comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial
- Time Frame: 2 and 24 hours respectively
Safety Issue?: Yes
- Time Frame: 2 and 24 hours respectively
- need of a rescue drug for lack of effect in every arms of the trial
- Time Frame: 2 hours and 24 hours for relapses
Safety Issue?: Yes
- Time Frame: 2 hours and 24 hours for relapses
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: 17 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: IRCCS Burlo Garofolo Other
Overall Clinical Trial Officials and Contacts
Edoardo Guglia, MD Principal Investigator IRCCS Burlo Garofolo
Overall Contact: Edoardo Guglia, MD +390403785373 edigugl@gmail.com
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00557544
Study ID Number: rc 32/07
ClinicalTrials.gov Identifier: NCT00557544
Health Authority: Italy: Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00557544
