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Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydromorphone
Prochlorperazine
Diphenhydramine
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center--Einstein

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hydromorphone

Prochlorperazine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Needing Rescue Medication as Assessed by Questionnaire
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.
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
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.
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
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.

Full Information

First Posted
March 10, 2015
Last Updated
August 1, 2018
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02389829
Brief Title
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Official Title
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydromorphone
Arm Type
Active Comparator
Arm Description
Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour.
Arm Title
Prochlorperazine
Arm Type
Active Comparator
Arm Description
Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour.
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Other Intervention Name(s)
Dilaudid
Intervention Type
Drug
Intervention Name(s)
Prochlorperazine
Other Intervention Name(s)
Compazine
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Other Intervention Name(s)
Benadryl
Primary Outcome Measure Information:
Title
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Description
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.
Time Frame
up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
Secondary Outcome Measure Information:
Title
Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Description
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.
Time Frame
48 hours after discharge from Emergency Department
Title
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Description
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.
Time Frame
48 hours after discharge from Emergency Department
Title
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Description
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.
Time Frame
48 hours after discharge from Emergency Department

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Friedman, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center--Einstein
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34363617
Citation
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.
Results Reference
derived
PubMed Identifier
29046364
Citation
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.
Results Reference
derived

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Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

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