Prochlorperazine vs Metoclopramide

Sponsor

Montefiore Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00364806

Collaborator

Albert Einstein College of Medicine (Other)

Enrollment

Location

Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Migraine headaches are a common reason for patients to present to an emergency department. We are comparing two different medications to see which one is better for patients who present ot an emergency room with a migraine headache.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Prochlorperazine Drug: Metoclopramide	Phase 4

Detailed Description

One-third of the five million headache patients who present to US Emergency Departments (ED) annually have a migraine headache. The anti-emetic dopamine receptor antagonists have proven efficacy for migraines, are at least as well-tolerated as triptans, and enjoy wide-spread use in North American EDs. However, it is not yet clear which medication within this class and which dosage is optimal. Therefore, we propose a randomized clinical trial to compare the efficacy and tolerability of two standard medications for migraine.

Specific Aim: To compare the efficacy of metoclopramide versus prochlorperazine for the emergency department treatment of migraine headaches. Both of these medications will be combined with diphenhydramine to prevent extra-pyramidal side effects.

Patients will be enrolled as participants if they present to one of the participating EDs and consent to participate. Medications will be administered as an intravenous drip over 15 minutes. Rescue medication will be administered, if needed, after one hour. A follow-up phone call will be conducted 24 hours after the ED visit.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting

Study Start Date :

Aug 1, 2006

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

One hour pain scores []

Secondary Outcome Measures

One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Present to the Ed with an acute migraine headache

Exclusion Criteria:

secondary headache
if the patient is to receive a lumbar puncture in the ED
maximum temperature greater than 100.3 degrees
new objective neurologic abnormality at the time of physical exam
allergy or intolerance to a study medication
pregnancy
previous enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

Montefiore Medical Center
Albert Einstein College of Medicine

Investigators

Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center

ClinicalTrials.gov Identifier:

NCT00364806

Other Study ID Numbers:

06-06-311

First Posted:

Aug 16, 2006

Last Update Posted:

Apr 17, 2018

Last Verified:

Apr 1, 2018

Keywords provided by Benjamin W. Friedman, MD, Prof. Emergency Medicine, Montefiore Medical Center

Migraine

Headache

Additional relevant MeSH terms:

Migraine Disorders

Metoclopramide

Prochlorperazine

Study Results

No Results Posted as of Apr 17, 2018