Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

Completed · Phase 2 · Has a placebo group

Conditions studied: Dental Anesthesia Efficacy

In brief

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.

Key facts

Study ID

NCT01302483

Run by

St. Renatus, LLC

People needed

45

Starts

2008-12-01

Expected to finish

2009-01-01

Last updated by the study team

2015-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Buffalo — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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