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Headache is a common presenting complaint to the emergency department accounting for 1-2% of patient visits. Of these headaches, approximately 90% are migraine, tension headache, or combined presentations. The most commonly used migraine therapy in the ED is intravenous prochlorperazine, but its administration requires close nursing observation, a bed, and the insertion of an intravenous catheter. Buccal prochlorperazine represents an alternative form of delivery that enables rapid achievement of therapeutic blood levels and may lead to symptom resolution. In a randomized, controlled, prospective study,the investigators plan to assess the efficacy of buccal versus intravenous prochlorperazine for the initial emergency department treatment of migraine headaches.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buccal Prochlorperazine | Experimental | Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline |
|
| Intravenous Prochlorperazine | Active Comparator | Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prochlorperazine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in median pian VAS score | Primary end point will be a detectable difference in the median pain VAS score recorded from Time 0 (baseline) to Time 60 minutes (conclusion of the study) for each of the two groups. | From Time 0 (baseline) to Time 60 minutes after administration of medication |
| Measure | Description | Time Frame |
|---|---|---|
| Change in median sedation VAS scores | Secondary endpoints will include a detectable difference in median sedation VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups. | From Time 0 (baseline) to Time 60 minutes after administration of medication |
| Change in median nausea VAS scores |
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Inclusion Criteria:
Exclusion Criteria:
Patients with the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| David Tanen, MD | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2018 | |
| Reset | Dec 24, 2018 | |
| Release | Mar 18, 2021 | |
| Reset | Apr 12, 2021 | |
| Release | Jun 8, 2021 | |
| Reset | Jun 28, 2021 | |
| Release | Jul 28, 2021 | |
| Reset | Aug 20, 2021 | |
| Release | Feb 16, 2026 | |
| Reset | Mar 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2018 | Dec 24, 2018 | |||
| Mar 18, 2021 |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011346 | Prochlorperazine |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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Secondary endpoints will include a detectable difference in median nausea VAS scale from Time 0 (baseline) to Time 60 minutes (conclusion of the study for each of the two groups. |
| From Time 0 (baseline) to Time 60 minutes after administration of medication |
| Rescue Medication | Comparison between groups for the need for rescue medication as determined by the primary care provider. | At the conclusion of the study (60 minutes) |
| Follow-up for persistence or recurrence of headache | Using a Pain Relief Scale, subjects will be contacted by telephone at 24 - 48 hours after the conclusion of the study and asked to rate their current headache pain. | 24 -48 hours |
| Apr 12, 2021 |
| Jun 8, 2021 | Jun 28, 2021 |
| Jul 28, 2021 | Aug 20, 2021 |
| Feb 16, 2026 | Mar 6, 2026 |
| D009422 | Nervous System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |