Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by IRCCS Burlo Garofolo.
Recruitment status was  Not yet recruiting
Information provided by:
IRCCS Burlo Garofolo Identifier:
First received: November 13, 2007
Last updated: January 28, 2009
Last verified: January 2009

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

Condition Intervention Phase
Drug: metoclopramide
Drug: placebo
Drug: ketoprofen
Phase 3

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
Official Title: Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child

Resource links provided by NLM:

Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • evaluation of healing times from pain in the 3 groups [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
Drug: metoclopramide
metoclopramide 0,15 mg/kg
Drug: ketoprofen
ketoprofen 1 mg/Kg
Active Comparator: 2
metoclopramide 0,15 mg/Kg + placebo per os
Drug: metoclopramide
metoclopramide 0,15 mg/kg
Drug: placebo
placebo per os
Active Comparator: 3
ketoprofen 1 mg/Kg and placebo in single dose
Drug: placebo
placebo per os
Drug: ketoprofen
ketoprofen 1 mg/Kg


Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00557544

Contact: Edoardo Guglia, MD +390403785373
Contact: Federico Minen, MD +390403785263

Edoardo Guglia Not yet recruiting
Trieste, Italy, 34100
Contact: angela De Cunto, MD    +390403785333   
Contact: Patrizia Salierno, MD    +390403785373   
Sponsors and Collaborators
IRCCS Burlo Garofolo
Principal Investigator: Edoardo Guglia, MD IRCCS Burlo Garofolo
  More Information

Responsible Party: IRCCS Burlo Garofolo, Edoardo Guglia Identifier: NCT00557544     History of Changes
Other Study ID Numbers: rc 32/07 
Study First Received: November 13, 2007
Last Updated: January 28, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Burlo Garofolo:

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Autonomic Agents
Cyclooxygenase Inhibitors
Dopamine Agents
Dopamine Antagonists
Dopamine D2 Receptor Antagonists
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 23, 2016