Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-10-31

Brief Summary

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Opioids are commonly used to treat migraine in North American Emergency Departments. We are comparing efficacy and adverse events of hydromorphone, an opioid, to that of prochlorperazine, a dopamine antagonist with known efficacy in migraine. Prochlorperazine will be combined with diphenhydramine to prevent adverse events.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hydromorphone

Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.

Group Type ACTIVE_COMPARATOR

Hydromorphone

Intervention Type DRUG

Prochlorperazine

Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.

Patients can receive second 10mg dose at 1 hour.

Group Type ACTIVE_COMPARATOR

Prochlorperazine

Intervention Type DRUG

Diphenhydramine

Intervention Type DRUG

Interventions

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Hydromorphone

Intervention Type DRUG

Prochlorperazine

Intervention Type DRUG

Diphenhydramine

Intervention Type DRUG

Other Intervention Names

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Dilaudid Compazine Benadryl

Eligibility Criteria

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Inclusion Criteria

* Migraine headache (International Classification of Headache Disorders 3B criteria)

Exclusion Criteria

* Brain imaging ordered
* Fever
* Objective neurological findings
* Pregnancy/ breast feeding
* Allergy/ contraindication to investigational medication
* History of addiction to opioids, use of methadone, any use of opioids previous 30 days

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No