Phase 4
N=127
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02389829 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation — 20; 37 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydromorphone (Drug); Prochlorperazine (Drug); Diphenhydramine (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Headache Relief Assessed by Self-evaluation |
20; 37 | — |
| SECONDARY Number of Participants Needing Rescue Medication as Assessed by Questionnaire |
23; 4 | — |
| SECONDARY Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire |
33; 53 | — |
| SECONDARY Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire |
16; 29 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02389829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.