Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia
Condition: Dental Anesthesia Efficacy
Intervention: 3% tetracaine HCL with 0.05% oxymetazoline HCL; Lidocaine Injection
Intervention description: 1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg.; Each subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays.
Intervention MeSH terms: Lidocaine; Phenylephrine; Oxymetazoline; Tetracaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study was to determine the safety and efficacy of Kovacaine Mist (3%
      tetracaine HCl with 0.05% oxymetazoline HCl) for anesthesia of the maxillary teeth for dental
      procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 18 and 65 years of age

          -  Sufficiently healthy as determined by the investigator to receive the test and control
             medications and undergo the scheduled dental procedure

          -  Required an operative restorative procedure on a single maxillary tooth, other than a
             maxillary second or third molar, with treatment time not expected to exceed 60 minutes

          -  Could breathe through both nostrils

          -  Had normal lip, nose, eyelid, and cheek sensations

          -  Could understand and sign the informed consent document

          -  Could communicate with the investigator

          -  Could understand and comply with the requirements of the protocol

        Exclusion Criteria:

          -  Clinically relevant history or presence of respiratory, gastrointestinal, renal,
             hepatic, hematological, lymphatic, cardiovascular, psychiatric, musculoskeletal,
             neurologic, genitourinary, infective, inflammatory, immunological, dermatological, or
             connective tissue disease or disorder or a clinically relevant history or presence of
             angle-closure glaucoma

          -  Clinically relevant sinus/nasal surgical history

          -  Baseline Visual Analog Scale value of > 36 (or greater than weak) at the treatment
             site

          -  Had not had dental work requiring a local anesthetic within the last 24 hours or had
             taken pain medications within the last 48 hours

          -  Required prophylactic antibiotics for subacute bacterial endocarditis (infectious
             endocarditis)

          -  Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or
             p-aminobenzoic acid (PABA), as found in PABA-containing sunscreens

          -  Allergic to or intolerant of oxymetazoline, epinephrine, or preservatives in their
             solutions

          -  Had a current condition, such as nasal congestion or sinus infection, that may have
             influenced responses to study medications

          -  History of alcoholism and/or drug abuse

          -  Had taken a monamine oxidase inhibitor within the past 3 weeks

          -  Were nursing, pregnant, suspected of being pregnant, or trying to become pregnant
             (females were required to take a urine pregnancy test to rule out pregnancy)

          -  Had used any investigational drug and/or participated in any clinical trial within 30
             days of baseline