Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Renatus, LLC
• Collaborators: Ground Zero Pharmaceuticals; Rho, Inc.
• Treatments: Lidocaine; Oxymetazoline; Phenylephrine; Tetracaine

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