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Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
This study is not yet open for participant recruitment.
Study NCT00557544   Information provided by IRCCS Burlo Garofolo
First Received: November 13, 2007   Last Updated: January 28, 2009   History of Changes

November 13, 2007
January 28, 2009
February 2009
December 2009   (final data collection date for primary outcome measure)
evaluation of healing times from pain in the 3 groups [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
evaluation of healing times from pain in the 3 groups [ Time Frame: 2 hours ]
Complete list of historical versions of study NCT00557544 on ClinicalTrials.gov Archive Site
  • 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 ]
evaluation of failures and necessity of rescue treatment after 2 hours and after 24 hours [ Time Frame: 24 hours ]
 
Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
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

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Migraine
  • Drug: metoclopramide
  • Drug: placebo
  • Drug: ketoprofen
  • Experimental: metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
  • Active Comparator: metoclopramide 0,15 mg/Kg + placebo per os
  • Active Comparator: ketoprofen 1 mg/Kg and placebo in single dose
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
120
June 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact: Edoardo Guglia, MD +390403785373 edigugl@gmail.com
Contact: Federico Minen, MD +390403785263 angela.decunto@libero.it
Italy
 
NCT00557544
IRCCS Burlo Garofolo, Edoardo Guglia
rc 32/07
IRCCS Burlo Garofolo
 
Principal Investigator: Edoardo Guglia, MD IRCCS Burlo Garofolo
IRCCS Burlo Garofolo
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP