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

Phase 4

Completed

• Conditions: Migraine Disorders
• Interventions: Drug: Metoclopramide 10 mg; Drug: Placebo; Drug: Fentanyl

• Registration Number: NCT02314351
• Lead Sponsor: Kocaeli University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-11
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous metoclopramide	Metoclopramide 10 mg	Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)
Intravenous metoclopramide	Placebo	Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)
Placebo	Placebo	0.9% normal saline solution (total 100 mL)
Placebo	Fentanyl	0.9% normal saline solution (total 100 mL)
Placebo	Metoclopramide 10 mg	0.9% normal saline solution (total 100 mL)
Intravenous metoclopramide	Fentanyl	Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)

Primary Outcome Measures

Name	Time	Method
The difference between pain scores for both drugs	15th and 30th minutes	The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups

Secondary Outcome Measures

Name	Time	Method
Nausea and vomiting	30th minute	Change in nausea/vomiting status of the participants
Adverse reactions	30th minute	Number of participants with adverse events
Need for rescue analgesic	30th minute	Number of patients needed rescue analgesic at 30th minute
Change in the headache intensity	Between 24th and 72th hours	Change in the headache intensity
Duplicative presentation to the emergency department	Between 24th and 72th hours	With telephone call

Trial Locations

Locations (1)

Kocaeli University, Faculty of Medicine; 🇹🇷 Kocaeli, Turkey