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

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ClinicalTrials.gov Identifier: NCT03962634
Recruitment Status : Suspended (Drug is not currently available, manufacturer does not expect new supply for 4 - 6 months.)
First Posted : May 24, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE May 21, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE August 28, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
Success rate of pupal anesthesia [ Time Frame: immediately after dental procedure, an average of 3 hours ]
% dental procedures completed without the need for rescue anesthesia
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03962634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • Spread of anesthesia [ Time Frame: immediately after dental procedure, an average of 3 hours ]
    Number of teeth anesthetized in maxillary arch
  • Change in Anxiety level [ Time Frame: 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.
  • Anxiety [ Time Frame: 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)
  • Change in Blood pressure [ Time Frame: from baseline to immediately after dental procedure ]
  • Change in heart rate [ Time Frame: from baseline to immediately after dental procedure ]
  • Change in pain [ Time Frame: from baseline to immediately after dental procedure ]
    Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • Spread of anesthesia [ Time Frame: immediately after dental procedure, an average of 3 hours ]
    Number of teeth anesthetized in maxillary arch
  • Change in Anxiety level - adults [ Time Frame: from baseline to immediately after dental procedure ]
    Modified Dental Anxiety Scale - 5 item questionnaire assessing dental visit related anxiety on a 5 point scale ranging from 1 (not anxious) to 5 (extremely anxious). Scores range from 5 to 25.
  • Change in Anxiety level - children [ Time Frame: 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.
  • Anxiety - children [ Time Frame: 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)
  • Change in Blood pressure [ Time Frame: from baseline to immediately after dental procedure ]
  • Change in heart rate [ Time Frame: from baseline to immediately after dental procedure ]
  • Change in pain - adults [ Time Frame: from baseline to immediately after dental procedure ]
    Heft-Parker visual analog scale rated from none (0mm) to maximum possible (170mm)
  • Change in pain - children [ Time Frame: from baseline to immediately after dental procedure ]
    Emoji scale ranging from 1 (very negative face) to 7 (very positive face)
  • Satisfaction with Kovanaze - adults [ Time Frame: immediately after dental procedure, an average of 3 hours ]
    8-item questionnaire with a variety of scales designed to measure satisfaction with Kovanaze
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric
Official Title  ICMJE Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth: A Randomized Clinical Trial
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Caries,Dental
  • Apical Periodontitis
Intervention  ICMJE
  • Drug: Kovanaze Nasal Spray
    Intra-nasal local anesthetic
    Other Name: Tetracaine HCl, Oxymetazoline HCl, NDC # 69803‐100‐10
  • Drug: Articaine Injection
    Local anesthetic
    Other Name: Septocaine
Study Arms  ICMJE
  • Experimental: Kovanaze Nasal Spray (Pediatrics)
    Children >20 kg who require pulpotomy, restorative procedures, SS crowns in one maxillary tooth
    Intervention: Drug: Kovanaze Nasal Spray
  • Active Comparator: Articaine Injections (Pediatrics)
    Children >20 kg who require pulpotomy, restorative procedures, or stainless steel crowns in one maxillary tooth
    Intervention: Drug: Articaine Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2019)
180
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03962634
Other Study ID Numbers  ICMJE HM20014136 - pediatric
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Parthasarathy Madurantakam, DDS, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP