Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department - Tabular View

Tracking Information

First Received Date ^ICMJE

December 13, 2007

Last Updated Date

December 13, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Difference in pain measured by VAS [ Time Frame: 80 min ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Degree of sedation, nausea, akathisia [ Time Frame: 80 min ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

Official Title ^ICMJE

Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Migraine Headache

Intervention ^ICMJE

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

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Acute migraine headache

Exclusion Criteria:

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00573599

Responsible Party

Dr Frank Gutierrez, US Navy

Study ID Numbers ^ICMJE

P06-050

Study Sponsor ^ICMJE

United States Naval Medical Center, Portsmouth

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Frank Gutierrez, MD

US Navy

Information Provided By

United States Naval Medical Center, Portsmouth

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP