Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

Phase 2 Completed 45 enrolled St. Renatus, LLC Ground Zero Pharmaceuticals · collab Rho, Inc. · collab

RandomizedParallel-groupDouble-blindSupportive care

Summary

The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental procedures.

Timeline

Start: 2008-12
Primary completion: 2009-01
Completion: 2009-01

Publications

Ciancio SG, Hutcheson MC, Ayoub F, Pantera EA Jr, Pantera CT, Garlapo DA, Sobieraj BD, Almubarak SA. Safety and efficacy of a novel nasal spray for maxillary dental anesthesia. J Dent Res. 2013 Jul;92(7 Suppl):43S-8S. doi: 10.1177/0022034513484334. Epub 2013 May 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lidocaine	Other / unclassified	—	Other
Subject	Oxymetazoline	Other / unclassified	0.3 mg	Intranasal
Subject	tetracaine	Other / unclassified	18 mg	Intranasal

Indications

No indication recorded.