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.
Brief Title
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
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
* 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
Inclusion Criteria
Inclusion Criteria:
* Migraine headache (International Classification of Headache Disorders 3B criteria)
* Migraine headache (International Classification of Headache Disorders 3B criteria)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT02389829
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2014-4325
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
Primary Outcomes
Outcome 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.
Outcome Measure
Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Outcome Time Frame
up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
Secondary Outcomes
Outcome 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.
Outcome Time Frame
48 hours after discharge from Emergency Department
Outcome Measure
Number of Participants Needing Rescue Medication as Assessed by Questionnaire
Outcome 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.
Outcome Time Frame
48 hours after discharge from Emergency Department
Outcome Measure
Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire
Outcome 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.
Outcome Time Frame
48 hours after discharge from Emergency Department
Outcome Measure
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415