Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Information source: Montefiore Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Hydromorphone (Drug); Prochlorperazine (Drug); Diphenhydramine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Montefiore Medical Center Official(s) and/or principal investigator(s): Benjamin W Friedman, MD, MS, Principal Investigator, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Overall contact: Belinda Tavarez, Phone: 718-920-6626, Email: btavarez@montefiore.org
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.
Clinical Details
Official title: Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Sustained headache relief
Secondary outcome: Rescue medicationShort term headache relief/ head freedom
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Belinda Tavarez, Phone: 718-920-6626, Email: btavarez@montefiore.org
Montefiore Medical Center--Moses, Bronx, New York 10467, United States; Recruiting Belinda Tavarez, Phone: 718-920-6626, Email: btavarez@montefiore.org
Additional Information
Starting date: March 2015
Last updated: June 8, 2015
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