Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Anesthesia Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kovacaine Nasal Spray

3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril

Group Type EXPERIMENTAL

3% tetracaine HCL with 0.05% oxymetazoline HCL

Intervention Type DRUG

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.

Lidocaine Injection

.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine

Group Type ACTIVE_COMPARATOR

Lidocaine Injection

Intervention Type DRUG

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.

Interventions

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3% tetracaine HCL with 0.05% oxymetazoline HCL

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.

Intervention Type DRUG

Lidocaine Injection

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 Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes