Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Study Overview
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Brief Summary
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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.

Official Title
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Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Prochlorperazine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18-65 years of age evaluated in the emergency department at Harbor-UCLA with migraine headache as defined by the Headache Classification Committee of the International Headache Society. (Patients must have had at least one prior similar headache, with or without nausea, vomiting, aura, photophobia, or phonophobia). Only subjects able to consent to treatment will be included. Exclusion Criteria: Patients with the following conditions: pregnancy breastfeeding fever greater or equal to 100.4 degrees diastolic blood pressure of 105 or higher altered mental status meningeal signs suspicion for intracranial process requiring further investigation known allergy to prochlorperazine the use of ergotamines, antiemetics, antipsychotics or sedatives in the previous 24 hours of study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buccal Prochlorperazine<br>Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline | Drug: Prochlorperazine<br> <br> |
| Active Comparator: Intravenous Prochlorperazine<br>Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets. | Drug: Prochlorperazine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |