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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Disorders
• Intervention / Treatment: Drug: Metoclopramide 10 mg; Drug: Placebo; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41000
    • Kocaeli University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.9% normal saline solution (total 100 mL)	Drug: Metoclopramide 10 mg; Intravenous form of metoclopramide is in the same appearance with placebo; Other Names: Metoclopramide 10 mg (2 mL) in 100 mL normal saline; Drug: Placebo; Intravenous form of metoclopramide is in the same appearance with placebo; Other Names: 100 mL normal saline; Drug: Fentanyl; Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute; Other Names: Intravenous fentanyl
Active Comparator: Intravenous metoclopramide; Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)	Drug: Metoclopramide 10 mg; Intravenous form of metoclopramide is in the same appearance with placebo; Other Names: Metoclopramide 10 mg (2 mL) in 100 mL normal saline; Drug: Placebo; Intravenous form of metoclopramide is in the same appearance with placebo; Other Names: 100 mL normal saline; Drug: Fentanyl; Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute; Other Names: Intravenous fentanyl

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Nurettin Özgür Doğan, Assoc. Prof, Kocaeli University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Estimate): January 4, 2017
• Last Update Submitted That Met QC Criteria: January 3, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: emergency department; pain management; migraine with aura; migraine without aura; migraine disorders
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adjuvants, Anesthesia; Fentanyl; Metoclopramide
• Other Study ID Numbers: KOU KAEK 2014/315