A Prospective, Randomized, Double-Blind Study Comparing the Efficacy of Sphenopalatine Nerve Block by Localized Mucosal Application of an Anesthetic vs Placebo for the Emergency Department Management

Indiana University1 site in 1 country93 target enrollmentOctober 2012

ConditionsHeadache Migraine

InterventionsBupivacaine Placebo

DrugsBupivacaine Placebo

Overview

Phase: Phase 3
Intervention: Bupivacaine
Conditions: Headache
Sponsor: Indiana University
Enrollment: 93
Locations: 1
Primary Endpoint: Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the duration of the analgesia.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

December 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Indiana University

Responsible Party

Principal Investigator

Jason Schaffer

Primary Investigator

Indiana University

Eligibility Criteria

Inclusion Criteria

•are 18 - 65 years of age
•present to emergency department (ED) triage with chief complaint of crescendo-onset anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and mandible region)
•have a normal neurological exams

Exclusion Criteria

•are less than 18 years old or greater than 65
•have any focal neurological dysfunction signs or symptoms
•have a posterior/occipital/cervicogenic source predominance of headache
•are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis, such as congestion, has been present more than 10 days, there is a high fever, the nasal mucus is an abnormal color, or complains of face pain or headaches
•have self treated with pain medication or anti-emetic 4 hours prior to arrival
•have a history of peripheral vascular disease, cancer, or HIV infection
•are known to be pregnant