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

• Status: Terminated
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Anesthetics; Carticaine; Oxymetazoline; Tetracaine

Criteria

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.