Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Adults
Condition: Anesthesia
Intervention: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%; Placebo
Intervention description: The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth; The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.
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: 150.0
Sex: All
Minimum age: 18 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 adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 years of age or older.

          -  Need for an operative restorative dental procedure requiring local anesthesia for a
             single vital maxillary tooth (anterior or premolar tooth #4 to #13) with no evidence
             of pulpal pathology.

          -  Normal lip, nose, eyelid, and cheek sensation.

          -  Able to understand and sign the study informed consent document, communicate with the
             Investigators, and understand and comply with the requirements of the protocol.

          -  Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure
             (the treatment tooth).

          -  Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.

          -  Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated
             diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.

        Exclusion Criteria:

          -  Inadequately controlled hypertension (blood pressure greater than 150/100 mm Hg).

          -  Inadequately controlled active thyroid disease of any type.

          -  Frequent nose bleeds (≥ 5 per month).

          -  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 articaine, 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.)

          -  Having received any investigational drug and/or participation in any clinical trial
             within the 30 days prior to study participation.

          -  History of congenital or idiopathic methemoglobinemia.