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Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01302483
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : June 17, 2015
Last Update Posted : June 17, 2015
Sponsor:
Collaborators:
Ground Zero Pharmaceuticals
Rho, Inc.
Information provided by (Responsible Party):
St. Renatus, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dental Anesthesia Efficacy Drug: 3% tetracaine HCL with 0.05% oxymetazoline HCL Drug: Lidocaine Injection Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase II, Single-Center, Randomized, Double-Blind, Active-Treatment-Controlled, Parallel-Group Study of the Efficacy of Kovacaine Nasal Spray for Anesthetizing Maxillary Teeth in Healthy Dental Patients
Study Start Date : December 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Kovacaine Nasal Spray
3% tetracaine HCL with 0.05% oxymetazoline HCL - Delivered via 3 sprays (100 uL) in each nostril
 Drug: 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.
Active Comparator: Lidocaine Injection
.5 to 1 catridge of 2% lidocaine HCL with 1:100,000 epinephrine
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Pulpal Anesthesia [ Time Frame: 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 :
  1. Soft Tissue Anesthesia Duration [ Time Frame: 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)

  2. Maximum Change in Pulse From Baseline [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes ]
    Maximum change from Baseline at any time point.

  3. Maximum Change in Blood Pressure From Baseline [ Time Frame: Baseline, 15, 20, 30, 40 50, 60, 120 minutes ]
    Maximum change from Baseline at any time point.

  4. Maximum Change in Pulse Oximetry From Baseline [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes ]
    Maximum change from Baseline at any time point


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302483


Locations
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United States, New York
University of Buffalo
Buffalo, New York, United States
Sponsors and Collaborators
St. Renatus, LLC
Ground Zero Pharmaceuticals
Rho, Inc.
Investigators
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Principal Investigator: Sebastian G Ciancio, DDS Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01302483    
Other Study ID Numbers: SR 2-01
First Posted: February 24, 2011    Key Record Dates
Results First Posted: June 17, 2015
Last Update Posted: June 17, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Lidocaine
Phenylephrine
Oxymetazoline
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Sympathomimetics
Autonomic Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents