Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
Overview
- Phase
- Phase 3
- Intervention
- Prochlorperazine
- Conditions
- Migraine Disorders
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in median pian VAS score
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
David Tanen
Professor of Medicine
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Eligibility Criteria
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.
Arms & Interventions
Buccal Prochlorperazine
Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline
Intervention: Prochlorperazine
Intravenous Prochlorperazine
Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets.
Intervention: Prochlorperazine
Outcomes
Primary Outcomes
Change in median pian VAS score
Time Frame: From Time 0 (baseline) to Time 60 minutes after administration of medication
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.
Secondary Outcomes
- Change in median sedation VAS scores(From Time 0 (baseline) to Time 60 minutes after administration of medication)
- Rescue Medication(At the conclusion of the study (60 minutes))
- Change in median nausea VAS scores(From Time 0 (baseline) to Time 60 minutes after administration of medication)
- Follow-up for persistence or recurrence of headache(24 -48 hours)