Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric

November 13, 2020 updated by: Virginia Commonwealth University

Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial

The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.

Study Overview

Detailed Description

In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. [9] Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face. Even though success rates between 83 and 90 % have been reported for adults and children >40kg, [10] FDA label (Section 14.2) provides data for children (>10 kg) indicating that the drug is safe for use in children as long as the dose is adjusted to bodyweight of the child. [9]

  • One 0.1 mL spray for patients weighing 10 kg to less than 20 kg;
  • Two 0.1 mL sprays for 20 kg to less than 40 kg; or
  • Two 0.2 mL sprays for patients weighing 40 kg or more.

With the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:

  1. Compare Kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing > 20 kg)
  2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists Class I or II
  • Preoperative heart rate of 55 to 100 beats per minute
  • Maximum blood pressure reading of 166/100 mmHg
  • Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia

Additional Pediatric Inclusion Criteria:

  • Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Additional Endodontic Inclusion Criteria:

  • Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

Additional General Practice Inclusion Criteria:

  • Adults who require restorations in the maxillary teeth that would need local anesthesia

Exclusion Criteria:

  • Inadequately controlled thyroid disease
  • Five or more nosebleeds in the past month
  • Known allergy to any study drug or para-aminobenzoic acid
  • History of methemoglobinemia
  • Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
  • Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Kovanaze Nasal Spray (Pediatrics)
Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
Intra-nasal local anesthetic
Other Names:
  • Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10
ACTIVE_COMPARATOR: Articaine Injections (Pediatrics)
Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
Local anesthetic
Other Names:
  • Septocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Pupal Anesthesia
Time Frame: immediately after dental procedure, an average of 3 hours
% dental procedures completed without the need for rescue anesthesia
immediately after dental procedure, an average of 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spread of Anesthesia
Time Frame: immediately after dental procedure, an average of 3 hours
Number of teeth anesthetized in maxillary arch
immediately after dental procedure, an average of 3 hours
Change in Anxiety Level
Time Frame: from baseline to immediately after dental procedure
STAI-Y6 - 6 item youth questionnaire assessing anxiety on a 4 point scale ranging from 1 (Not at all) to 4 (very much). Scores range from 6 to 24.
from baseline to immediately after dental procedure
Anxiety
Time Frame: immediately after dental procedure, an average of 3 hours
Venham Behavior rating scale - single item 6 point scale used by provider to rate child's behavior during treatment. Item ranges from 0 (no protest) to 5 (high protest, no cooperation from child)
immediately after dental procedure, an average of 3 hours
Change in Blood Pressure
Time Frame: from baseline to immediately after dental procedure
from baseline to immediately after dental procedure
Change in Heart Rate
Time Frame: from baseline to immediately after dental procedure
from baseline to immediately after dental procedure
Change in Pain
Time Frame: from baseline to immediately after dental procedure
Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
from baseline to immediately after dental procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 28, 2019

Primary Completion (ACTUAL)

September 17, 2019

Study Completion (ACTUAL)

September 17, 2019

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (ACTUAL)

May 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Apical Periodontitis

Clinical Trials on Kovanaze Nasal Spray

Subscribe