Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
Condition: Anesthesia
Intervention: 400uL of Kovacaine Mist; 200uL of Kovacaine Mist; 120uL of Kovacaine Mist
Intervention description: 2 unilateral intranasal sprays of 200uL each.; 2 unilateral intranasal sprays of 100uL each.; 2 unilateral intranasal sprays of 60uL each.
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tetracaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: operative; dental procedure

Summary:

      The purpose of this study is to assess the efficacy and safety of intranasally administered
      Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 3-17 years of age inclusive.

          -  Need for an operative restorative dental procedure on a single vital maxillary primary
             tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first,
             second or third molar, requiring local anesthesia with an expected treatment duration
             not exceeding 60 minutes.

          -  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.

          -  If age 8 and above, able to understand and provide informed assent.

          -  Patient or parent/guardian able to communicate with the investigator and comply with
             the requirements of the protocol.

          -  Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.

          -  Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg
             (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).

        Exclusion Criteria:

          -  Dental care requiring a local anesthetic within the 24 hours prior to anticipated
             study participation.

          -  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 take a urine pregnancy test on the day
             of, but prior to, study drug administration to rule out pregnancy.)

          -  Inadequately controlled thyroid disease of any type.

          -  Use of 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).

          -  Anticipated need for use of oxymetazoline or phenylephrine nasal spray, nasal
             irrigation, or other nasal or oral decongestant on the day of the study procedure.

          -  History of congenital or idiopathic methemoglobinemia.

          -  Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion
             or sinus infections, or use of a "sinus medication" within the 48 hours prior to
             anticipated study participation.

          -  History of alcoholism and/or drug abuse.

          -  Pulpal pathology in the index tooth.

          -  Anticipated need for use of nitrous oxide before or during the Study Dental Procedure.

          -  Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary,
             cardiovascular, renal, gastrointestinal or hepatic disease or condition with
             manifestations that might confound interpretation of study results or make receipt of
             study medication a source of risk for adverse outcome.

          -  Fever defined as body temperature ≥100° (37°C) on the day of and prior to study drug
             administration.