Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

Acute Migraine Headache Clinical Trial

Official title:

Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573599
• Other study ID #: P06-050
• Status: Completed
• Phase: N/A
• First received: December 13, 2007
• Last updated: December 13, 2007
• Start date: February 2007
• Est. completion date: May 2007

Study information

• Verified date: December 2007
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Acute migraine headache

Exclusion Criteria:

• Pregnant

• Hypertension

• Chest pain

• < 18

• Allergy to any of the meds

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Migraine Headache
• Emergencies
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in pain measured by VAS		80 min	No
Secondary	Degree of sedation, nausea, akathisia		80 min	No