Clinical trial NCT02779959: Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
Official title: Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Migraine Disorders
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in median pian VAS score
timeFrame: From Time 0 (baseline) to Time 60 minutes after administration of medication
Secondary outcomes:
measure: Change in median sedation VAS scores
timeFrame: From Time 0 (baseline) to Time 60 minutes after administration of medication
measure: Change in median nausea VAS scores
timeFrame: From Time 0 (baseline) to Time 60 minutes after administration of medication
measure: Rescue Medication
timeFrame: At the conclusion of the study (60 minutes)
measure: Follow-up for persistence or recurrence of headache
timeFrame: 24 -48 hours
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: David Tanen, MD
role: PRINCIPAL_INVESTIGATOR
References: