Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects

This study has been completed.
Sponsor:
Collaborators:
Triligent International
Tegra Analytics
Information provided by (Responsible Party):
St. Renatus, LLC
ClinicalTrials.gov Identifier:
NCT01701505
First received: October 2, 2012
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.


Condition Intervention Phase
Anesthesia
Drug: 400uL of Kovacaine Mist
Drug: 200uL of Kovacaine Mist
Drug: 120uL of Kovacaine Mist
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Center, Open-Label, Randomized, Parallel-Groups, Dose-Ranging Study to Assess the Efficacy and Safety of Intranasally Administered Kovacaine Mist for Anesthetizing Maxillary Teeth in Pediatric Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Completion of the Study Dental Procedure without need for rescue by injection of local anesthetic(yes/no) [ Time Frame: at 14 minutes with a 3 minute window ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events (AEs) by age and dose. [ Time Frame: from baseline to 24 hours following drug administration ] [ Designated as safety issue: Yes ]
  • Naris examination (NE) to assess reactions to the study drug. [ Time Frame: At 120 Minutes ] [ Designated as safety issue: Yes ]
    The principal investigator will perform a visual inspection to note any abnormalities

  • Systolic Blood Pressure [ Time Frame: At 12 minutes and 120 minutes ] [ Designated as safety issue: Yes ]
  • Diastolic Blood Pressure [ Time Frame: At 12 minutes and 120 minutes ] [ Designated as safety issue: Yes ]
  • Heart Rate [ Time Frame: At 12 minutes and 120 minutes ] [ Designated as safety issue: Yes ]
  • Oxygen Saturation [ Time Frame: At 12 minutes and 120 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 48
Study Start Date: October 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kovacaine Mist High Dose
400uL of Kovacaine Mist, as 2 sprays of 200uL.
Drug: 400uL of Kovacaine Mist
2 unilateral intranasal sprays of 200uL each.
Other Name: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Experimental: Kovacaine Mist Mid Dose
200uL of Kovacaine Mist, as 2 sprays of 100uL.
Drug: 200uL of Kovacaine Mist
2 unilateral intranasal sprays of 100uL each.
Other Name: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Experimental: Kovacaine Mist Low Dose
120uL of Kovacaine Mist, as 2 sprays of 60uL.
Drug: 120uL of Kovacaine Mist
2 unilateral intranasal sprays of 60uL each.
Other Name: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%

Detailed Description:

This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

The study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female 3-17 years of age inclusive.
  • Need for an operative restorative dental procedure on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first, second or third molar, requiring local anesthesia with an expected treatment duration not exceeding 60 minutes.
  • Normal lip, nose, eyelid, and cheek sensation.
  • Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
  • If age 8 and above, able to understand and provide informed assent.
  • Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
  • Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure.
  • Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).

Exclusion Criteria:

  • Dental care requiring a local anesthetic within the 24 hours prior to anticipated study participation.
  • History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
  • History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
  • Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
  • Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
  • Inadequately controlled thyroid disease of any type.
  • Use of any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
  • Frequent nose bleeds (≥ 5 per month).
  • Anticipated need for use of oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure.
  • History of congenital or idiopathic methemoglobinemia.
  • Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion or sinus infections, or use of a "sinus medication" within the 48 hours prior to anticipated study participation.
  • History of alcoholism and/or drug abuse.
  • Pulpal pathology in the index tooth.
  • Anticipated need for use of nitrous oxide before or during the Study Dental Procedure.
  • Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary, cardiovascular, renal, gastrointestinal or hepatic disease or condition with manifestations that might confound interpretation of study results or make receipt of study medication a source of risk for adverse outcome.
  • Fever defined as body temperature ≥100° (37°C) on the day of and prior to study drug administration.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701505

Locations
United States, Colorado
Big Grins
Fort Collins, Colorado, United States, 80525
Sponsors and Collaborators
St. Renatus, LLC
Triligent International
Tegra Analytics
Investigators
Study Director: Paul A. Moore, DMD/PhD/MPH University of Pittsburgh
  More Information

No publications provided

Responsible Party: St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01701505     History of Changes
Other Study ID Numbers: SR 2-03
Study First Received: October 2, 2012
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Renatus, LLC:
operative
dental procedure

Additional relevant MeSH terms:
Tetracaine
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
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents

ClinicalTrials.gov processed this record on April 16, 2014