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

NCT ID: NCT03962634

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2019-09-17

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

Conditions

Caries,Dental; Apical Periodontitis

Keywords

Cavities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Kovanaze Nasal Spray (Pediatrics)

Children \>20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth

Group Type: EXPERIMENTAL

Kovanaze Nasal Spray

Intervention Type: DRUG

Intra-nasal local anesthetic

Articaine Injections (Pediatrics)

Children \>20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

Group Type: ACTIVE_COMPARATOR

Articaine Injection

Intervention Type: DRUG

Local anesthetic

Interventions

Kovanaze Nasal Spray

Intra-nasal local anesthetic

Intervention Type: DRUG

Articaine Injection

Local anesthetic

Intervention Type: DRUG

Other Intervention Names

Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10; Septocaine

Eligibility 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

• Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth

• Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Parthasarathy Madurantakam, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HM20014136 - pediatric

Identifier Type: -

Identifier Source: org_study_id