Back to resultsProchlorperazine vs Imitrex for Acute Migraine in the Emergency Department
Primary Purpose
Acute Migraine Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prochlorperazine and benadryl IV
Imitrex SubQ, saline IV
Sponsored by
About this trial
This is an interventional treatment trial for Acute Migraine Headache focused on measuring Migraine, Emergency, imitrex, prochlorperazine, Acute Migraine Headache in the Emergency Department
Eligibility Criteria
Inclusion Criteria:
- Acute migraine headache
Exclusion Criteria:
- Pregnant
- Hypertension
- Chest pain
- < 18
- Allergy to any of the meds
Sites / Locations
- Naval Medical Center Portsmouth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
prochlorperazine and benadryl IV, saline subQ
imitrex SubQ, saline IV
Outcomes
Primary Outcome Measures
Difference in pain measured by VAS
Secondary Outcome Measures
Degree of sedation, nausea, akathisia
Full Information
NCT ID
NCT00573599
First Posted
December 13, 2007
Last Updated
December 13, 2007
Sponsor
United States Naval Medical Center, Portsmouth
1. Study Identification
Unique Protocol Identification Number
NCT00573599
Brief Title
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
Official Title
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
United States Naval Medical Center, Portsmouth
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Migraine Headache
Keywords
Migraine, Emergency, imitrex, prochlorperazine, Acute Migraine Headache in the Emergency Department
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
prochlorperazine and benadryl IV, saline subQ
Arm Title
2
Arm Type
Active Comparator
Arm Description
imitrex SubQ, saline IV
Intervention Type
Drug
Intervention Name(s)
prochlorperazine and benadryl IV
Intervention Description
prochlorperazine and benadryl IV, saline subQ
Intervention Type
Drug
Intervention Name(s)
Imitrex SubQ, saline IV
Intervention Description
Imitrex SubQ, saline IV
Primary Outcome Measure Information:
Title
Difference in pain measured by VAS
Time Frame
80 min
Secondary Outcome Measure Information:
Title
Degree of sedation, nausea, akathisia
Time Frame
80 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute migraine headache
Exclusion Criteria:
Pregnant
Hypertension
Chest pain
< 18
Allergy to any of the meds
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Gutierrez, MD
Organizational Affiliation
US Navy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
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