Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-01-31

Brief Summary

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Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.

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Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intravenous metoclopramide

Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)

Group Type ACTIVE_COMPARATOR

Metoclopramide 10 mg

Intervention Type DRUG

Intravenous form of metoclopramide is in the same appearance with placebo

Placebo

Intervention Type DRUG

Intravenous form of metoclopramide is in the same appearance with placebo

Fentanyl

Intervention Type DRUG

Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute

Placebo

0.9% normal saline solution (total 100 mL)

Group Type PLACEBO_COMPARATOR

Metoclopramide 10 mg

Intervention Type DRUG

Intravenous form of metoclopramide is in the same appearance with placebo

Placebo

Intervention Type DRUG

Intravenous form of metoclopramide is in the same appearance with placebo

Fentanyl

Intervention Type DRUG

Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute

Interventions

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Metoclopramide 10 mg

Intravenous form of metoclopramide is in the same appearance with placebo

Intervention Type DRUG

Placebo

Intravenous form of metoclopramide is in the same appearance with placebo

Intervention Type DRUG

Fentanyl

Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute

Intervention Type DRUG

Other Intervention Names

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Metoclopramide 10 mg (2 mL) in 100 mL normal saline 100 mL normal saline Intravenous fentanyl

Eligibility Criteria

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Inclusion Criteria

* Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013)
* The patients older than 18 years
* Patients who agree to participate to the study by reading and signing the informed consent document

Exclusion Criteria

* The patients younger than 18 years
* Pregnants
* Patients taking any analgesic drugs last 2 hours
* Documented or declared allergy to metoclopramide
* Patients who are hemodynamically unstable
* Patients who do not agree to participate to the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No