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

Kocaeli University

Status and phase: Completed; Phase 4

Conditions: Migraine Disorders

Treatments: Drug: Placebo; Drug: Metoclopramide 10 mg; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02314351

KOU KAEK 2014/315

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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148 participants in 2 patient groups, including a placebo group

Intravenous metoclopramide

Active Comparator group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Metoclopramide 10 mg

Drug: Placebo

Placebo

Placebo Comparator group

Description:

0.9% normal saline solution (total 100 mL)

Treatment:

Drug: Fentanyl

Drug: Metoclopramide 10 mg

Drug: Placebo