Hydromorphone Versus Prochlorperazine + Diphenhydramine for Treatment of Acute Migraine. A Randomized, Emergency Department Based, Comparative Efficacy Study
| Registry | NCT02389829 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
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| Enrollment | 127 (Actual) |
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| Sponsor | Montefiore Medical Center (Other) |
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| Conditions | Migraine |
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| Interventions | Hydromorphone, Prochlorperazine, Diphenhydramine (Drug) |
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| Dates | start 2015-03-01, primary completion 2016-06-01, completion 2016-10-01, first posted 2015-03-17, last updated 2018-08-31 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Migraine All trials of Hydromorphone All trials of Prochlorperazine
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Hydromorphone | Active comparator | Drug: Hydromorphone | Hydromorphone 1mg, administered as intravenous drip over 5 minutes. Patients can receive second 1mg dose at 1 hour. |
| Prochlorperazine | Active comparator | Drug: Prochlorperazine; Drug: Diphenhydramine | Prochlorperazine 10mg, administered as intravenous drip over 5 minutes. Diphenhydramine 25mg co-administered.
Patients can receive second 10mg dose at 1 hour. |
- Hydromorphone (Drug), also known as Dilaudid
- Prochlorperazine (Drug), also known as Compazine
- Diphenhydramine (Drug), also known as Benadryl
+Outcome measures
Primary outcomes
- 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 outcomes
- 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.
- 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.
+Eligibility
Sex: All, ages: 21 Years to any
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
+Posted results
Participant flow
| Milestone | Hydromorphone | Prochlorperazine |
|---|
| Started | 64 | 63 |
| Completed | 64 | 62 |
| Not completed | 0 | 1 |
Outcome results
- Number of Participants With Sustained Headache Relief Assessed by Self-evaluation (Primary), Count of participants, Participants: Hydromorphone 20; Prochlorperazine 37
- Number of Participants Needing Rescue Medication as Assessed by Questionnaire (Secondary), Count of participants, Participants: Hydromorphone 23; Prochlorperazine 4
- Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire (Secondary), Count of participants, Participants: Hydromorphone 33; Prochlorperazine 53
- Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire (Secondary), Count of participants, Participants: Hydromorphone 16; Prochlorperazine 29
Adverse events
Time frame: Adverse events were assessed by patient-initiated reports. In several cases, the explicit adverse event name/description was not documented. These events were grouped into the category called "other". Adverse events assessed over 48 hours post-treatment.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Hydromorphone | 0/64 (0.0%) | 0/64 (0.0%) | 13/64 (20.3%) |
| Prochlorperazine | 0/63 (0.0%) | 0/63 (0.0%) | 7/63 (11.1%) |
Other adverse events by term
| Term | Organ system | Hydromorphone | Prochlorperazine |
|---|
| Dizzy | Nervous system disorders | 9/64 | 0/63 |
| Restlessness | General disorders | 0/64 | 3/63 |
| Other | General disorders | 4/64 | 4/63 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| Montefiore Medical Center--Einstein | The Bronx, New York | United States | |
+Publications
- Results publication: Cohen F, Friedman BW. A randomized study of IV prochlorperazine plus diphenhydramine versus IV hydromorphone for migraine-associated symptoms: A post hoc analysis. Headache. 2021 Sep;61(8):1227-1233. doi: 10.1111/head.14185. Epub 2021 Aug 7. PMID 34363617
- Results publication: Friedman BW, Irizarry E, Solorzano C, Latev A, Rosa K, Zias E, Vinson DR, Bijur PE, Gallagher EJ. Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology. 2017 Nov 14;89(20):2075-2082. doi: 10.1212/WNL.0000000000004642. Epub 2017 Oct 18. PMID 29046364
+Investigators