Prochlorperazine vs Metoclopramide

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364806
• Other study ID #: 06-06-311
• Status: Completed
• Phase: Phase 4
• First received: August 14, 2006
• Last updated: April 15, 2018
• Start date: August 2006
• Est. completion date: March 2007

Study information

• Verified date: April 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Prochlorperazine

• Metoclopramide

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One hour pain scores
Secondary	One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles.