Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

IRCCS Burlo Garofolo

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Migraine

Interventions

metoclopramideDRUG

metoclopramide 0,15 mg/kg

placeboDRUG

placebo per os

ketoprofenDRUG

ketoprofen 1 mg/Kg

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Edoardo Guglia

Trieste, Italy

Outcomes

Primary Outcomes

evaluation of healing times from pain in the 3 groups

Time frame: 2 hours

Secondary Outcomes

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

Data from ClinicalTrials.gov

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