Overview

This trial is active, not recruiting.

Condition migraine
Treatments hydromorphone, prochlorperazine, diphenhydramine
Phase phase 4
Sponsor Montefiore Medical Center
Start date March 2015
End date June 2016
Trial size 208 participants
Trial identifier NCT02389829, HM vs CPZ

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.
hydromorphone Dilaudid
(Active Comparator)
Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour.
prochlorperazine Compazine
diphenhydramine Benadryl

Primary Outcomes

Measure
Sustained headache relief
time frame: 48 hours

Secondary Outcomes

Measure
Rescue medication
time frame: 48 hours
Short term headache relief/ head freedom
time frame: 2 hours

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
Principal investigator Benjamin W Friedman, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Montefiore Medical Center.