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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Caries,Dental, Apical Periodontitis

Intervention / Treatment
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* Drug: Kovanaze Nasal Spray
* Drug: Articaine Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kovanaze Nasal Spray (Pediatrics)<br>Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth | Drug: Kovanaze Nasal Spray<br>* Intra-nasal local anesthetic<br>* Other names: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10;|
| Active Comparator: Articaine Injections (Pediatrics)<br>Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth | Drug: Articaine Injection<br>* Local anesthetic<br>* Other names: Septocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate of Pupal Anesthesia | % 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 | Number of teeth anesthetized in maxillary arch | immediately after dental procedure, an average of 3 hours | 
| Change in Anxiety Level | 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 | 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 |  | from baseline to immediately after dental procedure | 
| Change in Heart Rate |  | from baseline to immediately after dental procedure | 
| Change in Pain | Emoji scale ranging from 1 (very negative face) to 7 (very positive face) | from baseline to immediately after dental procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cavities