Sphenopalatine Nerve Block for Headache Tx360

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

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.

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