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Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02389829
First Posted: March 17, 2015
Last Update Posted: February 28, 2017
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.
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
  Purpose
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 Intervention Phase
Migraine Drug: Hydromorphone Drug: Prochlorperazine Drug: Diphenhydramine Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Benjamin Friedman, Montefiore Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 127
Study Start Date: March 2015
Study Completion Date: October 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
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
United States, New York
Montefiore Medical Center--Einstein
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Benjamin W Friedman, MD, MS Albert Einstein College of Medicine, Inc.
  More Information

Responsible Party: Benjamin Friedman, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02389829     History of Changes
Other Study ID Numbers: HM vs CPZ
First Submitted: March 10, 2015
First Posted: March 17, 2015
Last Update Posted: February 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hydromorphone
Diphenhydramine
Prochlorperazine
Promethazine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anti-Allergic Agents
Antipruritics