Open-Label Study of Efficacy and Recommended Dose of Kovacaine Mist for Anesthetizing Maxillary Teeth
Condition: Anesthesia
Intervention: Kovacaine Mist 0.1 mL x 4 sprays; Kovacaine Mist 0.2 mL x 2 sprays; Kovacaine Mist 0.2 mL x 1 spray
Intervention description: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.; Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.; Dose = 1 intranasal spray of study drug
Intervention MeSH terms: Tetracaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: operative; dental procedure

Summary:

      The purpose of this study is to evaluate the efficacy of and recommended dosing regimen for
      unilateral administration of Kovacaine Mist in inducing pulpal anesthesia of the maxillary
      teeth for dental procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects who are 18 years of age or older;

          -  requiring an operative restorative procedure on a single maxillary tooth with no
             evidence of pulpal pathology requiring local anesthesia;

          -  having normal lip, nose, eyelid, and cheek sensations;

          -  able to understand and sign the informed consent document, communicate with the
             investigators, and understand and comply with the requirements of the protocol;

          -  having patency of naris on same side of head as tooth requiring the dental procedure.

        Exclusion Criteria:

          -  Inadequately controlled hypertension (blood pressures greater than 150/90) or
             untreated coronary heart disease;

          -  inadequately controlled thyroid disease including Hashimoto's thyroiditis and partial
             thyroidectomy;

          -  having frequent nose bleeds (10 per month);

          -  having received dental care requiring a local anesthetic within the last 24 hours;

          -  history of allergy to or intolerance of tetracaine, benzyl alcohol, benzocaine, other
             ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing
             sunscreens);

          -  history of allergy or hypersensitivity to articaine, oxymetazoline, epinephrine, or
             sulfite preservatives; history of taking a monoamine oxidase inhibitor within the past
             3 weeks;

          -  are nursing, pregnant, suspected of being pregnant, or trying to become pregnant.
             (Females will be required to take a urine pregnancy test on the day of but prior to
             study drug administration to rule out pregnancy);

          -  having used any investigational drug and/or participated in any clinical research
             trial within 30 days of baseline

          -  enlarged prostate

          -  narrow angle glaucoma

          -  use of oxymetazoline or phenylephrine nasal spray or oral decongestant on the day of
             the study

          -  congenital or idiopathic methemoglobinemia

          -  diabetes mellitus