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Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701505
First Posted: October 5, 2012
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Triligent International
Rho, Inc.
Information provided by (Responsible Party):
St. Renatus, LLC
Results First Submitted: November 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Anesthesia
Interventions: Drug: 400uL of Kovacaine Mist
Drug: 200uL of Kovacaine Mist
Drug: 120uL of Kovacaine Mist

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each.
Cohort A: 12-17 Years Mid-Dose (200uL Kovacaine Mist) 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each.
Cohort A: 12-17 Years HighDose (400uL Kovacaine Mist) 400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each.
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
Cohort B: 7-11 Years Med Dose 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
Cohort C: 3-6 Years Low Dose

120uL of Kovacaine Mist, as 2 sprays of 60uL

120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each


Participant Flow:   Overall Study
    Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)   Cohort A: 12-17 Years Mid-Dose (200uL Kovacaine Mist)   Cohort A: 12-17 Years HighDose (400uL Kovacaine Mist)   Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)   Cohort B: 7-11 Years Med Dose   Cohort C: 3-6 Years Low Dose
STARTED   8   8   8   8   8   8 
COMPLETED   8   8   8   8   8   8 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
Cohort A: 12-17 High Dose (400uL Kovacaine Mist) 400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
Total Total of all reporting groups

Baseline Measures
   Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)   Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)   Cohort A: 12-17 High Dose (400uL Kovacaine Mist)   Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)   Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)   Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   8   8   8   8   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.3  (1.75)   14.4  (2.00)   13.6  (1.19)   8.9  (1.64)   7.9  (0.83)   5.3  (1.04)   10.7  (3.85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      4  50.0%      8 100.0%      3  37.5%      6  75.0%      5  62.5%      2  25.0%      28  58.3% 
Male      4  50.0%      0   0.0%      5  62.5%      2  25.0%      3  37.5%      6  75.0%      20  41.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
             
Hispanic or Latino      2  25.0%      2  25.0%      2  25.0%      2  25.0%      0   0.0%      1  12.5%      9  18.8% 
Not Hispanic or Latino      6  75.0%      6  75.0%      6  75.0%      6  75.0%      8 100.0%      7  87.5%      39  81.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
             
American Indian or Alaska Native      0   0.0%      1  12.5%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1   2.1% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
White      8 100.0%      5  62.5%      7  87.5%      6  75.0%      8 100.0%      7  87.5%      41  85.4% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      2  25.0%      1  12.5%      2  25.0%      0   0.0%      1  12.5%      6  12.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.   [ Time Frame: at 14 minutes with a 3 minute window ]

2.  Secondary:   Naris Examination (NE) to Assess Reactions to the Study Drug.   [ Time Frame: At Baseline and 120 Minutes ]

3.  Secondary:   Systolic Blood Pressure   [ Time Frame: At Baseline, 12 minutes, and 120 minutes ]

4.  Secondary:   Diastolic Blood Pressure   [ Time Frame: At Baseline, 12 minutes, and 120 minutes ]

5.  Secondary:   Heart Rate   [ Time Frame: At Baseline, 12 minutes, and 120 minutes ]

6.  Secondary:   Oxygen Saturation   [ Time Frame: At Baseline, 12 minutes, and 120 minutes ]

7.  Secondary:   Number of Participants With Adverse Events by Dose Level and Age   [ Time Frame: from baseline to 24 hours following drug administration ]

8.  Secondary:   Incidence of Adverse Events by Dose Level Regardless of Age   [ Time Frame: from baseline to 24 hours following drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT 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.


Results Point of Contact:  
Name/Title: Dr. Gregory D. Evans, DDS
Organization: Big Grins Pediatric Dentistry
phone: 970-407-1020
e-mail: greg@biggrinswithdrgreg.com



Responsible Party: St. Renatus, LLC
ClinicalTrials.gov Identifier: NCT01701505     History of Changes
Other Study ID Numbers: SR 2-03
First Submitted: October 2, 2012
First Posted: October 5, 2012
Results First Submitted: November 8, 2016
Results First Posted: August 30, 2017
Last Update Posted: August 30, 2017