Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

December 13, 2007 updated by: United States Naval Medical Center, Portsmouth
ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center Portsmouth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute migraine headache

Exclusion Criteria:

  • Pregnant
  • Hypertension
  • Chest pain
  • < 18
  • Allergy to any of the meds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
prochlorperazine and benadryl IV, saline subQ
Drug: prochlorperazine and benadryl IV
prochlorperazine and benadryl IV, saline subQ
Active Comparator: 2
imitrex SubQ, saline IV
Drug: Imitrex SubQ, saline IV
Imitrex SubQ, saline IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in pain measured by VAS
Time Frame: 80 min
80 min

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of sedation, nausea, akathisia
Time Frame: 80 min
80 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Naval Medical Center, Portsmouth

Investigators

  • Principal Investigator: Frank Gutierrez, MD, US Navy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

December 14, 2007

Last Update Submitted That Met QC Criteria

December 13, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P06-050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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