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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Caries,Dental
• Apical Periodontitis

Interventions

Type	Name	Description
DRUG	Kovanaze Nasal Spray	Intra-nasal local anesthetic
DRUG	Articaine Injection	Local anesthetic

Timeline

• Start date: 2019-08-28
• Primary completion: 2019-09-17
• Completion: 2019-09-17
• First posted: 2019-05-24
• Last updated: 2020-11-19
• Results posted: 2020-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study