Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department

NCT ID: NCT00573599

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-05-31

Brief Summary

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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

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Conditions

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Acute Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

prochlorperazine and benadryl IV, saline subQ

Group Type EXPERIMENTAL

prochlorperazine and benadryl IV

Intervention Type DRUG

prochlorperazine and benadryl IV, saline subQ

2

imitrex SubQ, saline IV

Group Type ACTIVE_COMPARATOR

Imitrex SubQ, saline IV

Intervention Type DRUG

Imitrex SubQ, saline IV

Interventions

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prochlorperazine and benadryl IV

prochlorperazine and benadryl IV, saline subQ

Intervention Type DRUG

Imitrex SubQ, saline IV

Imitrex SubQ, saline IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute migraine headache

Exclusion Criteria

* Pregnant
* Hypertension
* Chest pain
* \< 18
* Allergy to any of the meds
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Naval Medical Center, Portsmouth

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Gutierrez, MD

Role: PRINCIPAL_INVESTIGATOR

US Navy

Locations

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Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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P06-050

Identifier Type: -

Identifier Source: org_study_id

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