Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
Condition: Anesthesia
Intervention: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Placebo
Intervention description: Intranasally administered regional anesthetic; Inactive ingredients supplied in identical nasal sprayer
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tetracaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: operative; dental procedure

Summary:

      The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for
      inducing pulpal anesthesia of the maxillary teeth in pediatric patients.
    

Eligibility criteria:

        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.