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Clinical Trials/NCT00364806
NCT00364806
Completed
Phase 4

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

Montefiore Medical Center1 site in 1 country76 target enrollmentAugust 2006

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Migraine
Sponsor
Montefiore Medical Center
Enrollment
76
Locations
1
Primary Endpoint
One hour pain scores
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
March 2007
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Benjamin W. Friedman, MD

Prof. Emergency Medicine

Montefiore Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

One hour pain scores

Secondary Outcomes

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

Study Sites (1)

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