search
Back to results

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

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Metoclopramide 10 mg
Placebo
Fentanyl
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring migraine disorders, migraine with aura, migraine without aura, pain management, emergency department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kocaeli University, Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intravenous metoclopramide

Placebo

Arm Description

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

0.9% normal saline solution (total 100 mL)

Outcomes

Primary Outcome Measures

The difference between pain scores for both drugs
The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups

Secondary Outcome Measures

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

Full Information

First Posted
December 5, 2014
Last Updated
January 3, 2017
Sponsor
Kirsehir Ahi Evran University
search

1. Study Identification

Unique Protocol Identification Number
NCT02314351
Brief Title
Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
Official Title
Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
migraine disorders, migraine with aura, migraine without aura, pain management, emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous metoclopramide
Arm Type
Active Comparator
Arm Description
Intravenous metoclopramide, 10 mg (2 mL) in 98 mL 0.9% normal saline solution (total 100 mL)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% normal saline solution (total 100 mL)
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 10 mg
Other Intervention Name(s)
Metoclopramide 10 mg (2 mL) in 100 mL normal saline
Intervention Description
Intravenous form of metoclopramide is in the same appearance with placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
100 mL normal saline
Intervention Description
Intravenous form of metoclopramide is in the same appearance with placebo
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Intravenous fentanyl
Intervention Description
Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute
Primary Outcome Measure Information:
Title
The difference between pain scores for both drugs
Description
The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups
Time Frame
15th and 30th minutes
Secondary Outcome Measure Information:
Title
Nausea and vomiting
Description
Change in nausea/vomiting status of the participants
Time Frame
30th minute
Title
Adverse reactions
Description
Number of participants with adverse events
Time Frame
30th minute
Title
Need for rescue analgesic
Description
Number of patients needed rescue analgesic at 30th minute
Time Frame
30th minute
Title
Change in the headache intensity
Description
Change in the headache intensity
Time Frame
Between 24th and 72th hours
Title
Duplicative presentation to the emergency department
Description
With telephone call
Time Frame
Between 24th and 72th hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurettin Özgür Doğan, Assoc. Prof
Organizational Affiliation
Kocaeli University, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University, Faculty of Medicine
City
Kocaeli
ZIP/Postal Code
41000
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs