Safety and Efficacy of a Novel Nasal Spray for Maxillary Dental Anesthesia

This study examines the efficacy,safety,and tolerability of a nasal spray to induce anesthesia of maxillary teeth. forty-five healthy adults requiring restoration of one maxillary tooth were randomized in a 1:2 ratio to receive (1) an intra-oral lidocaine-epinephrine injection with buffered saline nasal spray bilaterally,or (2) a tetracaine hydrochloride-oxymetazoline hydrochloride nasal spray bilaterally with sham injection. primary endpoints were use of rescue anesthesia and patient global pain assessment. secondary outcomes included vital sign changes,soft-tissue anesthesia,and treatment-emergent adverse events. in intent-to-treat analysis,25 of 30 patients given nasal spray (83.3%) did not require rescue anesthesia. proportion of anesthesia successes for nasal spray was significantly different from the hypothesized placebo anesthesia success of 30% (one-sided p value <.0001 by exact binomial test). mean duration of soft-tissue anesthesia did not differ significantly by treatment for 3 of 4 sites assessed. no serious adverse events or systemic effects were observed. tetracaine hydrochloride-oxymetazoline nasal spray appears to provide adequate and safe anesthesia for the majority of maxillary dental procedures. based on the results from this phase 2 study,pivotal trials are warranted to validate these findings in an expanded patient population (clinicaltrials.gov,nct01302483). © 2013,international & american associations for dental research. all rights reserved.