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Safety and Effectiveness of Kovacaine Nasal Spray for Dental Anesthesia

This study has been completed.
Sponsor:
Collaborator:
University at Buffalo
Information provided by:
St. Renatus, LLC
ClinicalTrials.gov Identifier:
NCT01302483
First received: February 18, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention Phase
Dental Anesthesia Efficacy
 Drug: 3% tetracaine hydrochloride plus 0.05% oxymetazoline hydrochloride
Drug: Lidocaine Injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Renatus, LLC:

Primary Outcome Measures:
  • Pain assessment (pulpal anesthesia) [ Time Frame: Continuous throughout dental treatment period (up to 60 minutes) ] [ Designated as safety issue: No ]
    Assessment of need for rescue anesthesia during a dental procedure. In addition, at Baseline, 15, 20, 60 minutes, the efficacy of anesthesia was assessed using the Heft-Parker visual analog scale


Secondary Outcome Measures:
  • Soft Tissue anesthesia [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 80, 100, 120 minutes ] [ Designated as safety issue: No ]
    Assessment of pain using a Rotadent sensor probe, applying up to 20 grams/cm2 at the tissue site.

  • Pulse and Pulse oximetry [ Time Frame: Baseline, 15, 20, 30, 40, 50, 60, 120 minutes ] [ Designated as safety issue: Yes ]
  • Blood Pressure [ Time Frame: Baseline, 15, 20, 30, 40 50, 60, 120 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: December 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kovacaine Nasal Spray Drug: 3% tetracaine hydrochloride plus 0.05% oxymetazoline hydrochloride
Each subject received both an injection (lidocaine or sham) and 3 doses of nasal spray (Kovacaine Nasal Spray or isotonic saline sham; each dose was 2 sprays with a single spray in each nostril and a 4-minute interval between subsequent doses). The total dose of tetracaine HCl/oxymetazoline HCl was 18 mg/0.3 mg.
Other Name: Kovacaine Nasal Spray
Active Comparator: Lidocaine Injection Drug: Lidocaine Injection
Each subject received both an injection (lidocaine or sham) and 3 doses of nasal spray (Kovacaine Nasal Spray or isotonic saline sham; each dose was 2 sprays with a single spray in each nostril and a 4-minute interval between subsequent doses).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 VAX > 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302483

Locations
United States, New York
University of Buffalo
Buffalo, New York, United States
Sponsors and Collaborators
St. Renatus, LLC
University at Buffalo
Investigators
Principal Investigator: Sebastian G Ciancio, DDS Department of Periodontics & Endodontics, School of Dental Medicine, University at Buffalo, SUNY
  More Information

No publications provided

Responsible Party: Jim Mulvahill, St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01302483     History of Changes
Other Study ID Numbers: SR 2-01
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tetracaine
Lidocaine
Oxymetazoline
Phenylephrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013