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

Migraine Disorders Clinical Trial

Official title:

Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791400
• Other study ID #: ASD-1213-70
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2013
• Last updated: February 13, 2013
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders

Intervention

Drug:
• metoclopramide, injection,20mg, one time
metoclopramide, intravenous injection,20mg, one time
• Sumatriptan, injection, 6 mg, one time
Sumatriptan, subcutaneous injection, 6 mg, one time

Locations

Country	Name	City	State
Iran, Islamic Republic of	Al-zahra university hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	determining pain in Metoclopramide versus sumatriptan groups	at one hour after prescription	Yes

External Links

•   Isfahan university of medical sciences