Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
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|ClinicalTrials.gov Identifier: NCT02389829|
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : June 5, 2018
Last Update Posted : August 31, 2018
|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|
|Actual Primary Completion Date :||June 2016|
|Actual 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: Compazine
Other Name: Benadryl
- Number of Participants With Sustained Headache Relief Assessed by Self-evaluation [ Time Frame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department ]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.
- Number of Participants Needing Rescue Medication as Assessed by Questionnaire [ Time Frame: 48 hours after discharge from Emergency Department ]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.
- Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire [ Time Frame: 48 hours after discharge from Emergency Department ]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.
- Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire [ Time Frame: 48 hours after discharge from Emergency Department ]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.
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.|