Phase 3
Completed N=93
Sphenopalatine Nerve Block for Headache Tx360
Source: ClinicalTrials.gov NCT01939314 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcomePrimary: Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale — 48.8; 41.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale |
48.8; 41.3 | — |
| SECONDARY Categorical Pain Relief |
13; 13; 6; 9; 3; 8 | — |
| SECONDARY Headache Free at 24 Hours |
72.2; 47.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01939314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.