Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

Study Overview
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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.

Official Title
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Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study

Conditions
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Migraine

Intervention / Treatment
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* Drug: Hydromorphone
* Drug: Prochlorperazine
* Drug: Diphenhydramine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydromorphone<br>Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. | Drug: Hydromorphone<br> <br> * Other names: Dilaudid;|
| Active Comparator: Prochlorperazine<br>Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. | Drug: Prochlorperazine<br> <br> * Other names: Compazine;Drug: Diphenhydramine<br> <br> * Other names: Benadryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Headache Relief Assessed by Self-evaluation | Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours, without use of addition medication. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration. | up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Needing Rescue Medication as Assessed by Questionnaire | Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication. | 48 hours after discharge from Emergency Department | 
| Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire | Participants were asked to make evaluation of pain status since discharge. Those achieving headache level mild or none for 1 hour are considered to achieve short term headache relief. | 48 hours after discharge from Emergency Department | 
| Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire | Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief. | 48 hours after discharge from Emergency Department |