Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache

February 13, 2013 updated by: Hamidreza Shemshaki, Isfahan University of Medical Sciences

Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache

The purpose of this study is to determine which drug makes lower migraine headache

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are different options to manage benign headache in emergency department.The investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve pain in emergency department.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20-60 years old and presented with acute headache similar to previous episodes,
  • with or without phonophobia,
  • photophobia,
  • vomiting or nausea.

Exclusion Criteria:

  • fever or neck stiffness,
  • altered mental state,
  • pregnancy,
  • recent trauma or seizure (within 24 hours),
  • focal neurological abnormality on physical examination,
  • allergy to metoclopramide,
  • hypertension,
  • cardiovascular diseases.

Also if the patients had taken a triptan or ergot during the last 24 hours were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: sumatriptan
Patients who underwent 6 mg sumatriptan subcutaneous one time
Drug: Sumatriptan, injection, 6 mg, one time
Sumatriptan, subcutaneous injection, 6 mg, one time
Other: Metoclopramide
Patients who underwent 20 mg Metoclopramide intravenous one time
Drug: metoclopramide, injection,20mg, one time
metoclopramide, intravenous injection,20mg, one time
Other Names:
  • plasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain
Time Frame: at one hour after prescription
determining pain in Metoclopramide versus sumatriptan groups
at one hour after prescription

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: babak masoumi, A.Professor, Isfahan, Isfahan, Iran, Islamic Republic of

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 10, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASD-1213-70

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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