Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Hydromorphone; Drug: Prochlorperazine; Drug: Diphenhydramine

Study type: Interventional

Funder types: Other

Identifiers

NCT02389829

2014-4325

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 2 patient groups

Hydromorphone

Active Comparator group

Description:

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

Treatment:

Drug: Hydromorphone

Prochlorperazine

Active Comparator group

Description:

Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour.

Treatment:

Drug: Diphenhydramine

Drug: Prochlorperazine