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

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03962634
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Days): 20
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries,Dental; Apical Periodontitis	Drug: Kovanaze Nasal Spray; Drug: Articaine Injection	Phase 2

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
• Actual Study Start Date: Aug 28, 2019
• Actual Primary Completion Date: Sep 17, 2019
• Actual Study Completion Date: Sep 17, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kovanaze Nasal Spray (Pediatrics) Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth	Drug: Kovanaze Nasal Spray; Intra-nasal local anesthetic; Other Names: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803-100-10
Active Comparator: Articaine Injections (Pediatrics) Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth	Drug: Articaine Injection; Local anesthetic; Other Names: Septocaine

Outcome Measures

Primary Outcome Measures

1. 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

1. Spread of Anesthesia [immediately after dental procedure, an average of 3 hours]

   Number of teeth anesthetized in maxillary arch

2. 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.

3. 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)

4. Change in Blood Pressure [from baseline to immediately after dental procedure]

5. Change in Heart Rate [from baseline to immediately after dental procedure]

6. Change in Pain [from baseline to immediately after dental procedure]

   Emoji scale ranging from 1 (very negative face) to 7 (very positive face)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Virginia Commonwealth University

Investigators

• Principal Investigator: Parthasarathy Madurantakam, DDS, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 28, 2019

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03962634
• Other Study ID Numbers: HM20014136 - pediatric
• First Posted: May 24, 2019
• Last Update Posted: Nov 19, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Virginia Commonwealth University: Cavities
• Additional relevant MeSH terms: Periodontitis; Periapical Periodontitis; Dental Caries; Oxymetazoline; Tetracaine; Carticaine

Study Results

Participant Flow

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Period Title: Overall Study
STARTED	1	2
COMPLETED	1	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)	Total
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic	Total of all reporting groups
Overall Participants	1	2	3
Age (years) [Mean (Standard Deviation) ]
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	2 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Success Rate of Pupal Anesthesia
Description	% dental procedures completed without the need for rescue anesthesia
Time Frame	immediately after dental procedure, an average of 3 hours

Outcome Measure Data

Analysis Population Description

Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Measure Participants	0	0

2. Secondary Outcome

Title	Spread of Anesthesia
Description	Number of teeth anesthetized in maxillary arch
Time Frame	immediately after dental procedure, an average of 3 hours

Outcome Measure Data

Analysis Population Description

Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Measure Participants	0	0

3. Secondary Outcome

Title	Change in Anxiety Level
Description	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.
Time Frame	from baseline to immediately after dental procedure

Outcome Measure Data

Analysis Population Description

Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Measure Participants	0	0

4. Secondary Outcome

Title	Anxiety
Description	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)
Time Frame	immediately after dental procedure, an average of 3 hours

Outcome Measure Data

Analysis Population Description

Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Measure Participants	0	0

5. Secondary Outcome

Title	Change in Blood Pressure
Time Frame	from baseline to immediately after dental procedure

Outcome Measure Data

Analysis Population Description

Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Measure Participants	0	0

6. Secondary Outcome

Title	Change in Heart Rate
Time Frame	from baseline to immediately after dental procedure

Outcome Measure Data

Analysis Population Description

Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Measure Participants	0	0

7. Secondary Outcome

Title	Change in Pain
Description	Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
Time Frame	from baseline to immediately after dental procedure

Outcome Measure Data

Analysis Population Description

Because of the low number of enrollees with only 1 in the treatment group, results are not reported to protect the confidentiality of the participants

Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)	Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic	Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
Measure Participants	0	0

Adverse Events

Time Frame	Up to 3 hours, the length of the dental procedure
Arm/Group Title	Kovanaze Nasal Spray (Pediatrics)		Articaine Injections (Pediatrics)
Arm/Group Description	Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth Kovanaze Nasal Spray: Intra-nasal local anesthetic		Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth Articaine Injection: Local anesthetic
All Cause Mortality
	Kovanaze Nasal Spray (Pediatrics)		Articaine Injections (Pediatrics)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)
Serious Adverse Events
	Kovanaze Nasal Spray (Pediatrics)		Articaine Injections (Pediatrics)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Kovanaze Nasal Spray (Pediatrics)		Articaine Injections (Pediatrics)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.