Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

NCT02389829 | Completed Phase 4 Results DMC

• 1 other identifier: 2014-4325
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Headache Relief Assessed by Self-evaluation

  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.

  up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department

Secondary Outcomes (3)

• Number of Participants Needing Rescue Medication as Assessed by Questionnaire

  48 hours after discharge from Emergency Department

• Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire

  48 hours after discharge from Emergency Department

• Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire

  48 hours after discharge from Emergency Department

Study Arms (2)

Hydromorphone

ACTIVE COMPARATOR

Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.

Drug: Hydromorphone

Prochlorperazine

ACTIVE COMPARATOR

Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour.

Drug: Prochlorperazine; Drug: Diphenhydramine

Interventions

Hydromorphone DRUG

Also known as: Dilaudid

Hydromorphone

Prochlorperazine DRUG

Also known as: Compazine

Prochlorperazine

Diphenhydramine DRUG

Also known as: Benadryl

Prochlorperazine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Migraine headache (International Classification of Headache Disorders 3B criteria)

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center--Einstein

The Bronx, New York, 10461, United States

Location

Related Publications (2)

• Cohen F, Friedman BW. A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis. Headache. 2021 Sep;61(8):1227-1233. doi: 10.1111/head.14185. Epub 2021 Aug 7.

  PMID: 34363617 DERIVED

• Friedman BW, Irizarry E, Solorzano C, Latev A, Rosa K, Zias E, Vinson DR, Bijur PE, Gallagher EJ. Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology. 2017 Nov 14;89(20):2075-2082. doi: 10.1212/WNL.0000000000004642. Epub 2017 Oct 18.

  PMID: 29046364 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Hydromorphone; Prochlorperazine; Diphenhydramine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Ethylamines; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Benjamin W. Friedman, MD, MS
• Organization: Montefiore Medical Center

befriedm@montefiore.org

718-920-6266

Study Officials

• Benjamin W Friedman, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 31, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-08

Locations

US (1)