Trial Outcomes & Findings for Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects (NCT NCT01701505)
NCT ID: NCT01701505
Last Updated: 2017-08-30
Results Overview
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
at 14 minutes with a 3 minute window
Results posted on
2017-08-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects
Baseline characteristics by cohort
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 Participants
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.3 years
STANDARD_DEVIATION 1.75 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 2.00 • n=7 Participants
|
13.6 years
STANDARD_DEVIATION 1.19 • n=5 Participants
|
8.9 years
STANDARD_DEVIATION 1.64 • n=4 Participants
|
7.9 years
STANDARD_DEVIATION 0.83 • n=21 Participants
|
5.3 years
STANDARD_DEVIATION 1.04 • n=10 Participants
|
10.7 years
STANDARD_DEVIATION 3.85 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
39 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
41 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: at 14 minutes with a 3 minute windowIf the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
Outcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 Participants
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
|
6 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At Baseline and 120 MinutesThe principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.
Outcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 Participants
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
|---|---|---|---|---|---|---|
|
Naris Examination (NE) to Assess Reactions to the Study Drug.
Post-dose ulceration (not present at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Naris Examination (NE) to Assess Reactions to the Study Drug.
Post-dose inflammation (not present at baseli
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Naris Examination (NE) to Assess Reactions to the Study Drug.
Post-dose minor bleeding (not present at baseline)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Baseline, 12 minutes, and 120 minutesOutcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 Participants
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
|---|---|---|---|---|---|---|
|
Systolic Blood Pressure
Baseline
|
113.1 mmHg
Standard Deviation 8.44
|
122.5 mmHg
Standard Deviation 11.41
|
115.4 mmHg
Standard Deviation 10.06
|
111.3 mmHg
Standard Deviation 7.59
|
106.5 mmHg
Standard Deviation 9.35
|
97.8 mmHg
Standard Deviation 8.36
|
|
Systolic Blood Pressure
12 mins
|
119.1 mmHg
Standard Deviation 12.19
|
122.3 mmHg
Standard Deviation 10.89
|
121.0 mmHg
Standard Deviation 21.21
|
105.5 mmHg
Standard Deviation 13.32
|
109.9 mmHg
Standard Deviation 6.53
|
101.9 mmHg
Standard Deviation 10.19
|
|
Systolic Blood Pressure
120 mins
|
120.5 mmHg
Standard Deviation 9.27
|
120.1 mmHg
Standard Deviation 10.32
|
116.4 mmHg
Standard Deviation 9.62
|
106.3 mmHg
Standard Deviation 8.84
|
102.3 mmHg
Standard Deviation 9.81
|
101.9 mmHg
Standard Deviation 16.16
|
SECONDARY outcome
Timeframe: At Baseline, 12 minutes, and 120 minutesOutcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 Participants
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
|---|---|---|---|---|---|---|
|
Diastolic Blood Pressure
Baseline
|
64.6 mmHg
Standard Deviation 6.93
|
70.9 mmHg
Standard Deviation 7.16
|
62.1 mmHg
Standard Deviation 9.37
|
65.0 mmHg
Standard Deviation 11.71
|
63.8 mmHg
Standard Deviation 6.96
|
61.0 mmHg
Standard Deviation 8.19
|
|
Diastolic Blood Pressure
12 mins
|
63.9 mmHg
Standard Deviation 3.40
|
68.4 mmHg
Standard Deviation 7.85
|
66.1 mmHg
Standard Deviation 10.96
|
62.0 mmHg
Standard Deviation 6.78
|
64.6 mmHg
Standard Deviation 4.78
|
60.4 mmHg
Standard Deviation 7.93
|
|
Diastolic Blood Pressure
120 mins
|
64.3 mmHg
Standard Deviation 10.67
|
69.0 mmHg
Standard Deviation 10.57
|
70.1 mmHg
Standard Deviation 8.51
|
65.0 mmHg
Standard Deviation 6.41
|
61.6 mmHg
Standard Deviation 8.47
|
66.1 mmHg
Standard Deviation 13.58
|
SECONDARY outcome
Timeframe: At Baseline, 12 minutes, and 120 minutesOutcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 Participants
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
|---|---|---|---|---|---|---|
|
Heart Rate
Baseline
|
72.9 bpm
Standard Deviation 10.55
|
83.6 bpm
Standard Deviation 12.95
|
75.5 bpm
Standard Deviation 14.80
|
90.3 bpm
Standard Deviation 15.04
|
80.6 bpm
Standard Deviation 7.41
|
90.1 bpm
Standard Deviation 7.66
|
|
Heart Rate
12 mins
|
75.4 bpm
Standard Deviation 10.06
|
80.9 bpm
Standard Deviation 12.43
|
77.3 bpm
Standard Deviation 18.52
|
91.6 bpm
Standard Deviation 15.14
|
82.5 bpm
Standard Deviation 9.01
|
89.3 bpm
Standard Deviation 11.59
|
|
Heart Rate
120 mins
|
78.4 bpm
Standard Deviation 11.02
|
84.3 bpm
Standard Deviation 14.58
|
76.1 bpm
Standard Deviation 10.45
|
91.9 bpm
Standard Deviation 13.01
|
86.9 bpm
Standard Deviation 7.10
|
95.0 bpm
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: At Baseline, 12 minutes, and 120 minutesOutcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 Participants
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
|---|---|---|---|---|---|---|
|
Oxygen Saturation
12 mins
|
97.3 percent
Standard Deviation 1.28
|
98.3 percent
Standard Deviation 1.49
|
97.9 percent
Standard Deviation 1.36
|
97.4 percent
Standard Deviation 1.30
|
96.3 percent
Standard Deviation 2.19
|
96.4 percent
Standard Deviation 0.74
|
|
Oxygen Saturation
120 mins
|
97.0 percent
Standard Deviation 0.93
|
97.4 percent
Standard Deviation 1.51
|
96.9 percent
Standard Deviation 1.64
|
96.0 percent
Standard Deviation 1.85
|
97.5 percent
Standard Deviation 1.31
|
97.5 percent
Standard Deviation 1.41
|
|
Oxygen Saturation
Baseline
|
97.3 percent
Standard Deviation 1.28
|
98.8 percent
Standard Deviation 1.75
|
98.3 percent
Standard Deviation 1.39
|
97.3 percent
Standard Deviation 1.49
|
97.4 percent
Standard Deviation 2.00
|
97.6 percent
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: from baseline to 24 hours following drug administrationPopulation: Patients grouped by age
Outcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=16 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=24 Participants
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
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events by Dose Level and Age
3-6 Years
|
—
|
—
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events by Dose Level and Age
7-11 Years
|
—
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events by Dose Level and Age
12-17 Years
|
8 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: from baseline to 24 hours following drug administrationOutcome measures
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 Participants
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=16 Participants
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=24 Participants
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
|
|---|---|---|---|---|---|---|
|
Incidence of Adverse Events by Dose Level Regardless of Age
|
8 Participants
|
12 Participants
|
20 Participants
|
—
|
—
|
—
|
Adverse Events
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist)
n=8 participants at risk
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist)
n=8 participants at risk
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort A: 12-17 High Dose (400uL Kovacaine Mist)
n=8 participants at risk
400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each
|
Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist)
n=8 participants at risk
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist)
n=8 participants at risk
200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each
|
Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist)
n=8 participants at risk
120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
25.0%
2/8 • 24 hours post-dosing
|
25.0%
2/8 • 24 hours post-dosing
|
50.0%
4/8 • 24 hours post-dosing
|
62.5%
5/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
37.5%
3/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
37.5%
3/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
25.0%
2/8 • 24 hours post-dosing
|
25.0%
2/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
12.5%
1/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
25.0%
2/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
37.5%
3/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
25.0%
2/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Hypoaesthesia
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Eye disorders
Lacrimation Increased
|
12.5%
1/8 • 24 hours post-dosing
|
25.0%
2/8 • 24 hours post-dosing
|
37.5%
3/8 • 24 hours post-dosing
|
62.5%
5/8 • 24 hours post-dosing
|
62.5%
5/8 • 24 hours post-dosing
|
37.5%
3/8 • 24 hours post-dosing
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
25.0%
2/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Nervous system disorders
Sensory Disturbance
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
General disorders
Pain
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
General disorders
Injection Site Pain
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
General disorders
Facial Pain
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
General disorders
Fatigue
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
|
Respiratory, thoracic and mediastinal disorders
Intranasal Hypoaesthesia
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
0.00%
0/8 • 24 hours post-dosing
|
12.5%
1/8 • 24 hours post-dosing
|
Additional Information
Dr. Gregory D. Evans, DDS
Big Grins Pediatric Dentistry
Phone: 970-407-1020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place