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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

• evaluation of healing times from pain in the 3 groups
  • Time Frame: 2 hours
    Safety Issue?: Yes

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
• 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

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

Lead Sponsor: IRCCS Burlo Garofolo

Overall Clinical Trial Officials and Contacts

Edoardo Guglia, MD Principal Investigator IRCCS Burlo Garofolo  

Overall Contact: Edoardo Guglia, MD +390403785373 edigugl@gmail.com

Information obtained from ClinicalTrials.gov on July 02, 2009

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