Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
Information source: IRCCS Burlo Garofolo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: metoclopramide (Drug); placebo (Drug); ketoprofen (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: IRCCS Burlo Garofolo Official(s) and/or principal investigator(s): Edoardo Guglia, MD, Principal Investigator, Affiliation: IRCCS Burlo Garofolo
Overall contact: Edoardo Guglia, MD, Phone: +390403785373, Email: edigugl@gmail.com
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
Clinical Details
Official title: Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: evaluation of healing times from pain in the 3 groups
Secondary outcome: comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trialneed of a rescue drug for lack of effect in every arms of the trial
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Edoardo Guglia, MD, Phone: +390403785373, Email: edigugl@gmail.com
Edoardo Guglia, Trieste 34100, Italy; Not yet recruiting angela De Cunto, MD, Phone: +390403785333, Email: angela.decunto@libero.it Patrizia Salierno, MD, Phone: +390403785373, Email: patty76@aliceposta.it
Additional Information
Starting date: February 2009
Last updated: January 28, 2009
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