Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric
- Conditions
- Caries,DentalApical Periodontitis
- Interventions
- Registration Number
- NCT03962634
- Lead Sponsor
- Virginia Commonwealth University
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Articaine Injections (Pediatrics) Articaine Injection Children \>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Kovanaze Nasal Spray (Pediatrics) Kovanaze Nasal Spray Children \>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
- Primary Outcome Measures
Name Time Method Success Rate of Pupal Anesthesia immediately after dental procedure, an average of 3 hours % dental procedures completed without the need for rescue anesthesia
- Secondary Outcome Measures
Name Time Method Spread of Anesthesia immediately after dental procedure, an average of 3 hours Number of teeth anesthetized in maxillary arch
Anxiety 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)
Change in Blood Pressure from baseline to immediately after dental procedure Change in Anxiety Level 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.
Change in Heart Rate from baseline to immediately after dental procedure Change in Pain from baseline to immediately after dental procedure Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
Trial Locations
- Locations (1)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States