Official Title: “Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: prochlorperazine and benadryl IV
  • prochlorperazine and benadryl IV, saline subQ
• Drug: Imitrex SubQ, saline IV
  • Imitrex SubQ, saline IV

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • prochlorperazine and benadryl IV, saline subQ
• Active Comparator: 2
  • imitrex SubQ, saline IV

Primary Measures

• Difference in pain measured by VAS
  • Time Frame: 80 min
    Safety Issue?: No

Secondary Measures

• Degree of sedation, nausea, akathisia
  • Time Frame: 80 min
    Safety Issue?: No

Inclusion Criteria:

• Acute migraine headache

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: United States Naval Medical Center, Portsmouth

Overall Clinical Trial Officials and Contacts

Frank Gutierrez, MD Principal Investigator US Navy  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573599

Study ID Number: P06-050

ClinicalTrials.gov Identifier: NCT00573599

Health Authority: United States: Federal Government