Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

Phase 2

Completed

Interventions: Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL
Drug: Lidocaine Injection

Brief 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.

Detailed Description: The primary objective of this single-center, randomized, double-blind, active-controlled, parallel-group study was to determine if Kovacaine Mist provided anesthesia of the maxillary teeth sufficient for the performance of dental procedures. Secondary objectives included a determination of whether Kovacaine Mist provided anesthesia of the soft tissue and to evaluate the safety and tolerability of Kovacaine Mist and sham injection as compared to sham nasal spray and 2% lidocaine hydrochloride with 1:100,000 epinephrine submucosal injection and as determined by changes in vital signs and reports of side effects and adverse events.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Kovacaine Nasal Spray	3% tetracaine HCL with 0.05% oxymetazoline HCL	3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril
Lidocaine Injection	Lidocaine Injection	.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine

Primary Outcome Measures

Name	Time	Method
Pulpal Anesthesia	Continuous throughout dental treatment period (up to 60 minutes)	Number of participants who did not need rescue anesthesia to complete the study dental procedure, i.e. Kovacaine provided enough pulpal anesthesia to complete a dental procedure.

Secondary Outcome Measures

Name	Time	Method
Soft Tissue Anesthesia Duration	Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes	Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm\^2 at the tissue site. At each time point, participants were asked if they felt pain from the sensor probe at each site location in the mouth. The four sites were: * Site 1: Distal to the apex of the tooth in the position of the maxillary first premolar at the deepest point in the buccal vestibule * Site 2: Apical to the maxillary lateral incisor at the deepest point in the labial vestibule * Site 3: Incisive papilla * Site 4: At the confluence of the alveolar process and hard palate medial to the maxillary second premolar (near the greater palatine foramen)
Maximum Change in Pulse From Baseline	Baseline, 15, 20, 30, 40, 50, 60, 120 minutes	Maximum change from Baseline at any time point.
Maximum Change in Blood Pressure From Baseline	Baseline, 15, 20, 30, 40 50, 60, 120 minutes	Maximum change from Baseline at any time point.
Maximum Change in Pulse Oximetry From Baseline	Baseline, 15, 20, 30, 40, 50, 60, 120 minutes	Maximum change from Baseline at any time point