Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

• Sponsor: United States Naval Medical Center, Portsmouth (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00573599
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 2.9
• Patients Per Site Per Month: 22.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Migraine Headache	Drug: prochlorperazine and benadryl IV; Drug: Imitrex SubQ, saline IV	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department
• Study Start Date: Feb 1, 2007
• Actual Study Completion Date: May 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Difference in pain measured by VAS [80 min]

Secondary Outcome Measures

1. Degree of sedation, nausea, akathisia [80 min]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute migraine headache

Exclusion Criteria:

• Pregnant

• Hypertension

• Chest pain

• < 18

• Allergy to any of the meds

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center Portsmouth	Portsmouth	Virginia	United States	23708

Sponsors and Collaborators

• United States Naval Medical Center, Portsmouth

Investigators

• Principal Investigator: Frank Gutierrez, MD, US Navy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00573599
• Other Study ID Numbers: P06-050
• First Posted: Dec 14, 2007
• Last Update Posted: Dec 14, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Migraine; Emergency; imitrex; prochlorperazine; Acute Migraine Headache in the Emergency Department
• Additional relevant MeSH terms: Migraine Disorders; Emergencies; Headache; Diphenhydramine; Prochlorperazine

Study Results

No Results Posted as of Dec 14, 2007