Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

IRCCS Burlo Garofolo

Status and phase: Withdrawn; Phase 3

Conditions: Migraine

Treatments: Drug: ketoprofen; Drug: placebo; Drug: metoclopramide

Study type: Interventional

Funder types: Other

Identifiers

NCT00557544

rc 32/07

Details and patient eligibility

About

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

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

1

Experimental group

Description:

metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose

Treatment:

Drug: ketoprofen

Drug: metoclopramide

2

Active Comparator group

Description:

metoclopramide 0,15 mg/Kg + placebo per os

Treatment:

Drug: placebo

Drug: metoclopramide

3

Active Comparator group

Description:

ketoprofen 1 mg/Kg and placebo in single dose

Treatment:

Drug: placebo

Drug: ketoprofen