Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood - Full Text View

Purpose

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
Child Migraine	Drug: metoclopramide and ketoprofen Drug: metoclopramide and placebo Drug: ketoprofen and placebo	Phase III

Genetics Home Reference related topics:

familial hemiplegic migraine

MedlinePlus related topics:

Migraine

ChemIDplus related topics:

Ketoprofen Metoclopramide Metoclopramide hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

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:

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

Estimated Enrollment:	120
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
1: Experimental metoclopramide 0,15 mg + ketoprofen 1 mg/kg per os	Drug: metoclopramide and ketoprofen metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
2: Active Comparator metoclopramide and placebo	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
3: Active Comparator ketoprofen and placebo	Drug: ketoprofen and placebo ketoprofen 1 mg/Kg and placebo in single dose

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557544

Contacts


Contact: Edoardo Guglia, MD	+390403785373	edigugl@gmail.com

Contact: Federico Minen, MD	+390403785263	angela.decunto@libero.it

Locations


Italy
	Edoardo Guglia	Not yet recruiting
	Trieste, Italy, 34100
	Contact: angela De Cunto, MD +390403785333 angela.decunto@libero.it
	Contact: Patrizia Salierno, MD +390403785373 patty76@aliceposta.it

Sponsors and Collaborators

IRCCS Burlo Garofolo

Investigators


Principal Investigator:	Edoardo Guglia, MD	IRCCS Burlo Garofolo

More Information

Study ID Numbers:	rc 32/07
First Received:	November 13, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00557544
Health Authority:	Italy: Ethics Committee

Keywords provided by IRCCS Burlo Garofolo:

migraine

metoclopramide

ketoprofen

child

Study placed in the following topic categories:

Ketoprofen

Dopamine

Migraine Disorders

Headache

Central Nervous System Diseases

Headache Disorders, Primary

Brain Diseases

Metoclopramide

Headache Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Gastrointestinal Agents

Antiemetics

Dopamine Antagonists

Enzyme Inhibitors

Pharmacologic Actions

Autonomic Agents

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Dopamine Agents

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	IRCCS Burlo Garofolo
Information provided by:	IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:	NCT00557544