Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status and phase: Unknown; Phase 3

Conditions: Migraine Disorders

Treatments: Drug: Prochlorperazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02779959

30590-01

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Buccal Prochlorperazine

Experimental group

Description:

Experimental arm of two buccally absorbable prochlorperazine tablets (6 mg) plus 2 cc IV saline

Treatment:

Drug: Prochlorperazine

Intravenous Prochlorperazine

Active Comparator group

Description:

Accepted Standard of care receiving 10 mg (2 cc) of intravenous prochlorperazine plus two saccharin absorbable placebo tablets.

Treatment:

Drug: Prochlorperazine