Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

August 1, 2018 updated by: Benjamin W. Friedman, MD, Montefiore Medical Center

Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center--Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hydromorphone
Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.
Drug: Hydromorphone
Other Names:
  • 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 Names:
  • Compazine
Drug: Diphenhydramine
Other Names:
  • Benadryl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Time Frame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Time Frame: 48 hours after discharge from Emergency Department
Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication.
48 hours after discharge from Emergency Department
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Time Frame: 48 hours after discharge from Emergency Department
Participants were asked to make evaluation of pain status since discharge. Those achieving headache level "mild" or "none" for 1 hour are considered to achieve short term headache relief.
48 hours after discharge from Emergency Department
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Time Frame: 48 hours after discharge from Emergency Department
Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief.
48 hours after discharge from Emergency Department

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Benjamin W Friedman, MD, MS, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-4325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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