Phase 4
Completed N=127
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine
Source: ClinicalTrials.gov NCT02389829 ↗Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation — 20; 37 Participants
◆ Published Evidence
Established
80citations · ~9 / year
Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine.
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.
Linked Publications (2)
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Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine.
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A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.