Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment

• Status: Withdrawn
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Purpose:

To evaluate anesthetic efficacy and overall patient experience with use of Kovanaze tetracaine/oxymetazoline nasal spray for root canal treatment of vital premolar and anterior teeth needing root canal treatment.

Participants:

30 adult patients with a vital upper anterior or premolar tooth (#4-13) with a diagnosis indicating need root canal treatment and who are seeking treatment in the UNC Chapel Hill School of Dentistry.

Procedures (methods):

Qualifying patients will be anesthetized with tetracaine/oxymetazoline nasal spray anesthetic in order to facilitate completion of their clinically required, standard of care root canal treatment. Research procedures include blood pressure monitoring and pain assessment using a visual analogue pain scale.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Oxymetazoline; Phenylephrine; 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

• Maxillary anterior tooth or premolar with a diagnosis or treatment plan which indicates root canal treatment

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.