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

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314351
• Other study ID #: KOU KAEK 2014/315
• Status: Completed
• Phase: Phase 4
• First received: December 5, 2014
• Last updated: January 3, 2017
• Start date: December 2014
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Drug:
• Metoclopramide 10 mg
Intravenous form of metoclopramide is in the same appearance with placebo
• Placebo
Intravenous form of metoclopramide is in the same appearance with placebo
• Fentanyl
Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute

Locations

Country	Name	City	State
Turkey	Kocaeli University, Faculty of Medicine	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Nausea and vomiting	Change in nausea/vomiting status of the participants	30th minute	Yes
Secondary	Adverse reactions	Number of participants with adverse events	30th minute	Yes
Secondary	Need for rescue analgesic	Number of patients needed rescue analgesic at 30th minute	30th minute	Yes
Secondary	Change in the headache intensity	Change in the headache intensity	Between 24th and 72th hours	Yes
Secondary	Duplicative presentation to the emergency department	With telephone call	Between 24th and 72th hours	Yes