Conditions: Anesthesia
Keywords: operative dental procedure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: yes

Brief 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.

Detailed description:
This is a Phase II single-center, open-label clinical trial with three dosing regimens, designed to determine the efficacy and optimal dose of the Kovacaine Mist intranasal delivery system for inducing pulpal anesthesia of maxillary teeth numbers 4-13 (maxillary right second premolar to maxillary left second premolar). Kovacaine will be administered intranasally on the same side of the midline as the tooth on which the procedure will be performed in three dosing cohorts \[four 100 μL, two 200 μL, or one 200 μL spray(s)\] of 10 subjects each. The first cohort receiving 4 sprays will be completed before initiating study of the remaining two cohorts, which will be treated using a randomized, parallel-group design. Administration: Subjects in the 4- and 2-spray cohorts will be administered the same total dose of 12 mg tetracaine HCl/0.2 mg oxymetazoline HCl. The 4-spray cohort will be treated with a sequence of four 100-μL sprays at intervals of 4 minutes. The 2-spray cohort will be treated with a sequence of two 200 μL sprays 4 minutes apart. The 1-spray cohort will be administered one 200 μL spray, a total dose of 6 mg tetracaine HCl/0.1 mg oxymetazoline HCl, which is half the dose of the 2-spray cohort. Rescue: If the study drug does not provide sufficient anesthesia to allow for completion of the dental procedure, a rescue injection of articaine will be administered.

Arms:
arm 1: Total dose: 12 mg tetracaine/0.2 mg oxymetazoline arm 2: Total dose: 12 mg tetracaine/0.2 mg oxymetazoline arm 3: Total dose: 6 mg tetracaine/0.1 mg oxymetazoline

Interventions: intervention 1: Kovacaine Mist 0.1 mL x 4 sprays intervention 2: Kovacaine Mist 0.2 mL x 2 sprays intervention 3: Kovacaine Mist 0.2 mL x 1 spray
Intervention descriptions: intervention 1: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals. intervention 2: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals. intervention 3: Dose = 1 intranasal spray of study drug

Protocol document: