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Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02389829
Recruitment Status : Completed
First Posted : March 17, 2015
Results First Posted : June 6, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Hydromorphone Drug: Prochlorperazine Drug: Diphenhydramine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hydromorphone
Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.
 Drug: Hydromorphone
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.

 Drug: Prochlorperazine
Other Name: Compazine

Drug: Diphenhydramine
Other Name: Benadryl


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
Montefiore Medical Center--Einstein
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Benjamin W. Friedman, MD, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02389829    
Other Study ID Numbers: 2014-4325
First Posted: March 17, 2015    Key Record Dates
Results First Posted: June 6, 2018
Last Update Posted: August 31, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Diphenhydramine
Promethazine
Hydromorphone
Prochlorperazine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents