Sphenopalatine Nerve Block for Headache Tx360
| Status: | Completed |
|---|---|
| Conditions: | Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | December 2013 |
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.
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
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