Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
- Conditions
- Migraine
- Interventions
- Registration Number
- NCT02389829
- Lead Sponsor
- Montefiore Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- Migraine headache (International Classification of Headache Disorders 3B 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydromorphone Hydromorphone Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. Prochlorperazine Prochlorperazine Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour. Prochlorperazine Diphenhydramine Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered. Patients can receive second 10mg dose at 1 hour.
- Primary Outcome Measures
Name Time Method Number of Participants With Sustained Headache Relief Assessed by Self-evaluation 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire 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.
Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire 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.
Number of Participants Needing Rescue Medication as Assessed by Questionnaire 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.
Trial Locations
- Locations (1)
Montefiore Medical Center--Einstein
🇺🇸Bronx, New York, United States