title: Double-masked, randomized, placebo-controlled study to evaluate the efficacy and tolerability of intranasal K305 (3% tetracaine plus 0.05% oxymetazoline) in anesthetizing maxillary teeth.
abstract: BACKGROUND
  The authors compared the local anesthetic efficacy and safety of an intranasally administered formulation of tetracaine and oxymetazoline (K305) with placebo in adult participants undergoing single dental restorative procedures in teeth nos. 4 through 13.
  
  
  METHODS
  The authors screened and allocated 150 participants in a double-masked, randomized fashion to either K305 or placebo nasal spray. The authors delivered the study drug as two 0.2-milliliter sprays separated by 4 minutes inside the nostril on the side ipsilateral to the tooth being treated. The authors administered a third 0.2-mL spray, if necessary, and administered 4% articaine with 1:200,000 epinephrine by means of injection if anesthesia was inadequate. Safety evaluations included participant reports of adverse events, vital signs, and alcohol sniff tests during the 2-hour study period and at a 1-day follow-up visit. The primary efficacy end point was anesthetic success defined as the completion of the dental procedure without the need for rescue injectable local anesthetic. The authors evaluated differences in success rates observed between K305 and placebo by using a 1-sided Fisher exact test.
  
  
  RESULTS
  The overall success rates were 88.0% (95% confidence interval, 80.0-93.6) and 28% (95% confidence interval, 16.2-42.5) for K305 and placebo, respectively (P < .0001). The most frequent adverse effects in the K305 group were rhinorrhea (57.0%) and nasal congestion (26.0%). No serious adverse events occurred during this study.
  
  
  CONCLUSIONS
  K305 was effective and well tolerated during restorative procedures in adult participants.
  
  
  CONCLUSIONS
  K305 provides a needleless alternative for obtaining maxillary pulpal anesthesia on premolars, canines, and incisors.
authors.forename: Elliot V
authors.initials: EV
authors.lastname: Hersh
authors.forename: Andres
authors.initials: A
authors.lastname: Pinto
authors.forename: Mana
authors.initials: M
authors.lastname: Saraghi
authors.forename: Najeed
authors.initials: N
authors.lastname: Saleh
authors.forename: Lisbeth
authors.initials: L
authors.lastname: Pulaski
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Gordon
authors.forename: Douglas
authors.initials: D
authors.lastname: Barnes
authors.forename: Gary
authors.initials: G
authors.lastname: Kaplowitz
authors.forename: Ira
authors.initials: I
authors.lastname: Bloom
authors.forename: Mohammad
authors.initials: M
authors.lastname: Sabti
authors.forename: Paul A
authors.initials: PA
authors.lastname: Moore
authors.forename: Sean
authors.initials: S
authors.lastname: Lee
authors.forename: Michael
authors.initials: M
authors.lastname: Meharry
authors.forename: David Y
authors.initials: DY
authors.lastname: He
authors.forename: Yiming
authors.initials: Y
authors.lastname: Li
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D000766:Anesthesia, Dental / Q000009:adverse effects / Q000379:methods*; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008437:Maxilla; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010109:Oxymetazoline / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013748:Tetracaine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014070:Tooth / Q000294:innervation
chemical_list: D000779:Anesthetics, Local; D004338:Drug Combinations; D014663:Nasal Decongestants; D013748:Tetracaine; D010109:Oxymetazoline
keywords: Dental local anesthesia; clinical trial; intranasal delivery; tetracaine, oxymetazoline