Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
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|ClinicalTrials.gov Identifier: NCT02389829|
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : February 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Drug: Hydromorphone Drug: Prochlorperazine Drug: Diphenhydramine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study|
|Study Start Date :||March 2015|
|Primary Completion Date :||June 2016|
|Study Completion Date :||October 2016|
Active Comparator: Hydromorphone
Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.
Other Name: Dilaudid
Active Comparator: Prochlorperazine
Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.
Patients can receive second 10mg dose at 1 hour.
Other Name: CompazineDrug: Diphenhydramine
Other Name: Benadryl
- Sustained headache relief [ Time Frame: 48 hours ]Achieve a headache level of mild or none within two hours of medication administration and maintain a level of mild or none for 48 hours without use of rescue medication
- Rescue medication [ Time Frame: 48 hours ]Need for additional medication to treat headache
- Short term headache relief/ head freedom [ Time Frame: 2 hours ]Achieve level of mild/ none (relief) or none (freedom)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389829
|United States, New York|
|Montefiore Medical Center--Einstein|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Benjamin W Friedman, MD, MS||Albert Einstein College of Medicine, Inc.|