Prochlorperazine vs Metoclopramide

Phase 4

Completed

• Conditions: Migraine

• Registration Number: NCT00364806
• Lead Sponsor: Montefiore Medical Center

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.

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 Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-14
• Study First Submitted QC: 2006-08-15
• Study First Posted: 2006-08-16
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-15
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
One hour pain scores

Secondary Outcome Measures

Name	Time	Method
One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States