Migraine Disorders
Conditions
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.
Interventions
DRUGProchlorperazine
Sponsors
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in median pian VAS score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in median sedation VAS scores | From Time 0 (baseline) to Time 60 minutes after administration of medication | 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. |
| Change in median nausea VAS scores | From Time 0 (baseline) to Time 60 minutes after administration of medication | 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. |
| Rescue Medication | At the conclusion of the study (60 minutes) | Comparison between groups for the need for rescue medication as determined by the primary care provider. |
| Follow-up for persistence or recurrence of headache | 24 -48 hours | 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. |
Countries
United States
Outcome results
None listed