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:

1. metoclopramide 0,15 mg/kg + placebo

2. metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg

3. 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

Intervention(s) in this Clinical Trial

• Drug: metoclopramide and ketoprofen
  • metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
• Drug: metoclopramide and placebo
  • metoclopramide 0,15 mg/Kg + placebo per os
• Drug: ketoprofen and placebo
  • ketoprofen 1 mg/Kg and placebo in single dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • metoclopramide 0,15 mg + ketoprofen 1 mg/kg per os
• Active Comparator: 2
  • metoclopramide and placebo
• Active Comparator: 3
  • ketoprofen and placebo

Primary Measures

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

Secondary Measures

• evaluation of failures and necessity of rescue treatment after 2 hours and after 24 hours
  • Time Frame: 24 hours
    

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 August 28, 2008

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