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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


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 medication

Short term headache relief/ head freedom


Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.


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


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

Page last updated: August 23, 2015

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