- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962634
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Compare Kovanaze to conventional needle anesthetic children (at least 6 years of age and weighing > 20 kg)
- Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Tooth Demineralization
- Tooth Diseases
- Jaw Diseases
- Periapical Diseases
- Periodontitis
- Dental Caries
- Periapical Periodontitis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Oxymetazoline
- Tetracaine
- Carticaine
Other Study ID Numbers
- HM20014136 - pediatric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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