Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients

Inclusion Criteria: * Male or female 3-17 years of age inclusive. * Need for an operative restorative dental procedure and requiring local anesthesia on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), with no evidence of pulpal pathology. * Normal lip, nose, eyelid, and cheek sensation. * Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document. * Subject able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation). * Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol. * Patency of the naris on the same side as the tooth undergoing the Study Dental Procedure (the Study Treatment Tooth). Exclusion Criteria: * Having received dental care requiring a local anesthetic within the 24 hours preceding study entry. * History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen). * History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives. * Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry. * Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to undergo urine testing on the day of, but prior to, study drug administration to rule out pregnancy.) * Inadequately controlled thyroid disease of any type. * Having received any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation. * Frequent nose bleeds (≥ 5 per month). * History of congenital or idiopathic methemoglobinemia. * Presence of an upper respiratory infection and/or fever defined as body temperature ≥100.4° (38°C) on the day of and prior to study drug administration.