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Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
Migraine Drug: metoclopramide Drug: placebo Drug: ketoprofen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]
  • need of a rescue drug for lack of effect in every arms of the trial [ Time Frame: 2 hours and 24 hours for relapses ]

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   (Child)
Sexes Eligible for Study:   All
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

Keywords provided by IRCCS Burlo Garofolo:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors processed this record on August 22, 2017