Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Migraine Disorders Clinical Trial

Official title:

Buccal Prochlorperazine Versus Intravenous Prochlorperazine for Migraine Headaches, a RCT

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02779959
• Other study ID #: 30590-01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 17, 2016
• Last updated: January 3, 2018
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: January 2018
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders

Intervention

Drug:
• Prochlorperazine

Locations

Country	Name	City	State
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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