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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557544

Enrollment

Registered

2007-11-14

Start date

2009-06-30

Completion date

2010-06-30

Last updated

2017-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

migraine, metoclopramide, ketoprofen, child

Brief summary

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

Interventions

DRUGmetoclopramide

metoclopramide 0,15 mg/kg

DRUGplacebo

placebo per os

DRUGketoprofen

ketoprofen 1 mg/Kg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
evaluation of healing times from pain in the 3 groups	2 hours

Secondary

Measure	Time frame
comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial	2 and 24 hours respectively
need of a rescue drug for lack of effect in every arms of the trial	2 hours and 24 hours for relapses

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026