Prochlorperazine vs Metoclopramide

Overview

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.

Full Title of Study: “Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: March 2007

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.

Interventions

  • Drug: Prochlorperazine
  • Drug: Metoclopramide

Clinical Trial Outcome Measures

Primary Measures

  • One hour pain scores

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Montefiore Medical Center
  • Collaborator
    • Albert Einstein College of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Benjamin W. Friedman, MD, Prof. Emergency Medicine – Montefiore Medical Center
  • Overall Official(s)
    • Benjamin W Friedman, MD, MS, Principal Investigator, Albert Einstein College of Medicine

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