Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02389829
• Other study ID #: 2014-4325
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Hydromorphone

• Prochlorperazine

• Diphenhydramine

Locations

Country	Name	City	State
United States	Montefiore Medical Center--Einstein	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	48 hours after discharge from Emergency Department
Secondary	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.	48 hours after discharge from Emergency Department
Secondary	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.	48 hours after discharge from Emergency Department