Anesthesia
Conditions
Keywords
operative, dental procedure
Brief summary
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.
Detailed description
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects. The study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.
Interventions
DRUG400uL of Kovacaine Mist
2 unilateral intranasal sprays of 200uL each.
DRUG200uL of Kovacaine Mist
2 unilateral intranasal sprays of 100uL each.
DRUG120uL of Kovacaine Mist
2 unilateral intranasal sprays of 60uL each.
Sponsors
Triligent International
Rho, Inc.
St. Renatus, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female 3-17 years of age inclusive. * Need for an operative restorative dental procedure on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), other than a maxillary permanent first, second or third molar, requiring local anesthesia with an expected treatment duration not exceeding 60 minutes. * Normal lip, nose, eyelid, and cheek sensation. * Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document. * If age 8 and above, able to understand and provide informed assent. * Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol. * Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure. * Minimum weight: Subjects in Cohorts A and B (age 6 and above) must weigh at least 20kg (44 lb.). Subjects in Cohort C (age 3 and above) must weigh at least 10kg (22 lb.).
Exclusion criteria
* Dental care requiring a local anesthetic within the 24 hours prior to anticipated study participation. * History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen). * History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives. * Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry. * Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.) * Inadequately controlled thyroid disease of any type. * Use of any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation. * Frequent nose bleeds (≥ 5 per month). * Anticipated need for use of oxymetazoline or phenylephrine nasal spray, nasal irrigation, or other nasal or oral decongestant on the day of the study procedure. * History of congenital or idiopathic methemoglobinemia. * Clinically relevant history of sinus/nasal surgery, recent epistaxis, nasal congestion or sinus infections, or use of a sinus medication within the 48 hours prior to anticipated study participation. * History of alcoholism and/or drug abuse. * Pulpal pathology in the index tooth. * Anticipated need for use of nitrous oxide before or during the Study Dental Procedure. * Any chronic or currently uncontrolled psychogenic, neurological, endocrine, pulmonary, cardiovascular, renal, gastrointestinal or hepatic disease or condition with manifestations that might confound interpretation of study results or make receipt of study medication a source of risk for adverse outcome. * Fever defined as body temperature ≥100° (37°C) on the day of and prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | at 14 minutes with a 3 minute window | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Naris Examination (NE) to Assess Reactions to the Study Drug. | At Baseline and 120 Minutes | The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding. |
| Systolic Blood Pressure | At Baseline, 12 minutes, and 120 minutes | — |
| Diastolic Blood Pressure | At Baseline, 12 minutes, and 120 minutes | — |
| Heart Rate | At Baseline, 12 minutes, and 120 minutes | — |
| Oxygen Saturation | At Baseline, 12 minutes, and 120 minutes | — |
| Number of Participants With Adverse Events by Dose Level and Age | from baseline to 24 hours following drug administration | — |
| Incidence of Adverse Events by Dose Level Regardless of Age | from baseline to 24 hours following drug administration | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each | 8 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each | 8 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) 400uL of Kovacaine Mist: 2 unilateral intranasal sprays of 200uL each | 8 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each | 8 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) 200uL of Kovacaine Mist: 2 unilateral intranasal sprays of 100uL each | 8 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) 120uL of Kovacaine Mist: 2 unilateral intranasal sprays of 60uL each | 8 |
| Total | 48 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 14.3 years STANDARD_DEVIATION 1.75 | 14.4 years STANDARD_DEVIATION 2 | 13.6 years STANDARD_DEVIATION 1.19 | 8.9 years STANDARD_DEVIATION 1.64 | 7.9 years STANDARD_DEVIATION 0.83 | 5.3 years STANDARD_DEVIATION 1.04 | 10.7 years STANDARD_DEVIATION 3.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 7 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 8 Participants | 5 Participants | 7 Participants | 6 Participants | 8 Participants | 7 Participants | 41 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 3 Participants | 6 Participants | 5 Participants | 2 Participants | 28 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 5 Participants | 2 Participants | 3 Participants | 6 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 8 | 5 / 8 | 8 / 8 | 6 / 8 | 7 / 8 | 8 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
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.
Time frame: at 14 minutes with a 3 minute window
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 6 Participants |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 7 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 8 Participants |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 5 Participants |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 7 Participants |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 4 Participants |
Secondary
Diastolic Blood Pressure
Time frame: At Baseline, 12 minutes, and 120 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | 12 mins | 63.9 mmHg | Standard Deviation 3.4 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | Baseline | 64.6 mmHg | Standard Deviation 6.93 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | 120 mins | 64.3 mmHg | Standard Deviation 10.67 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Diastolic Blood Pressure | 12 mins | 68.4 mmHg | Standard Deviation 7.85 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Diastolic Blood Pressure | Baseline | 70.9 mmHg | Standard Deviation 7.16 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Diastolic Blood Pressure | 120 mins | 69.0 mmHg | Standard Deviation 10.57 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Diastolic Blood Pressure | 12 mins | 66.1 mmHg | Standard Deviation 10.96 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Diastolic Blood Pressure | Baseline | 62.1 mmHg | Standard Deviation 9.37 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Diastolic Blood Pressure | 120 mins | 70.1 mmHg | Standard Deviation 8.51 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | Baseline | 65.0 mmHg | Standard Deviation 11.71 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | 12 mins | 62.0 mmHg | Standard Deviation 6.78 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | 120 mins | 65.0 mmHg | Standard Deviation 6.41 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Diastolic Blood Pressure | 12 mins | 64.6 mmHg | Standard Deviation 4.78 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Diastolic Blood Pressure | Baseline | 63.8 mmHg | Standard Deviation 6.96 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Diastolic Blood Pressure | 120 mins | 61.6 mmHg | Standard Deviation 8.47 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | Baseline | 61.0 mmHg | Standard Deviation 8.19 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | 120 mins | 66.1 mmHg | Standard Deviation 13.58 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Diastolic Blood Pressure | 12 mins | 60.4 mmHg | Standard Deviation 7.93 |
Secondary
Heart Rate
Time frame: At Baseline, 12 minutes, and 120 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | 12 mins | 75.4 bpm | Standard Deviation 10.06 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | Baseline | 72.9 bpm | Standard Deviation 10.55 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | 120 mins | 78.4 bpm | Standard Deviation 11.02 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Heart Rate | 12 mins | 80.9 bpm | Standard Deviation 12.43 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Heart Rate | Baseline | 83.6 bpm | Standard Deviation 12.95 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Heart Rate | 120 mins | 84.3 bpm | Standard Deviation 14.58 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Heart Rate | 12 mins | 77.3 bpm | Standard Deviation 18.52 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Heart Rate | Baseline | 75.5 bpm | Standard Deviation 14.8 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Heart Rate | 120 mins | 76.1 bpm | Standard Deviation 10.45 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | 12 mins | 91.6 bpm | Standard Deviation 15.14 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | Baseline | 90.3 bpm | Standard Deviation 15.04 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | 120 mins | 91.9 bpm | Standard Deviation 13.01 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Heart Rate | 12 mins | 82.5 bpm | Standard Deviation 9.01 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Heart Rate | Baseline | 80.6 bpm | Standard Deviation 7.41 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Heart Rate | 120 mins | 86.9 bpm | Standard Deviation 7.1 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | Baseline | 90.1 bpm | Standard Deviation 7.66 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | 120 mins | 95.0 bpm | Standard Deviation 4.54 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Heart Rate | 12 mins | 89.3 bpm | Standard Deviation 11.59 |
Secondary
Incidence of Adverse Events by Dose Level Regardless of Age
Time frame: from baseline to 24 hours following drug administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Incidence of Adverse Events by Dose Level Regardless of Age | 8 Participants |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Incidence of Adverse Events by Dose Level Regardless of Age | 12 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Incidence of Adverse Events by Dose Level Regardless of Age | 20 Participants |
Secondary
Naris Examination (NE) to Assess Reactions to the Study Drug.
The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.
Time frame: At Baseline and 120 Minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose inflammation (not present at baseli | 0 Participants |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose ulceration (not present at baseline | 0 Participants |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose minor bleeding (not present at baseline) | 1 Participants |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose inflammation (not present at baseli | 1 Participants |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose ulceration (not present at baseline | 0 Participants |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose minor bleeding (not present at baseline) | 1 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose inflammation (not present at baseli | 0 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose ulceration (not present at baseline | 0 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose minor bleeding (not present at baseline) | 0 Participants |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose inflammation (not present at baseli | 0 Participants |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose ulceration (not present at baseline | 0 Participants |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose minor bleeding (not present at baseline) | 0 Participants |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose inflammation (not present at baseli | 0 Participants |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose ulceration (not present at baseline | 0 Participants |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose minor bleeding (not present at baseline) | 0 Participants |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose ulceration (not present at baseline | 0 Participants |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose minor bleeding (not present at baseline) | 0 Participants |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Naris Examination (NE) to Assess Reactions to the Study Drug. | Post-dose inflammation (not present at baseli | 0 Participants |
Secondary
Number of Participants With Adverse Events by Dose Level and Age
Time frame: from baseline to 24 hours following drug administration
Population: Patients grouped by age
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Number of Participants With Adverse Events by Dose Level and Age | 12-17 Years | 8 Participants |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Number of Participants With Adverse Events by Dose Level and Age | 7-11 Years | 7 Participants |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Number of Participants With Adverse Events by Dose Level and Age | 12-17 Years | 5 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Number of Participants With Adverse Events by Dose Level and Age | 3-6 Years | 8 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Number of Participants With Adverse Events by Dose Level and Age | 7-11 Years | 6 Participants |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Number of Participants With Adverse Events by Dose Level and Age | 12-17 Years | 6 Participants |
Secondary
Oxygen Saturation
Time frame: At Baseline, 12 minutes, and 120 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | 12 mins | 97.3 percent | Standard Deviation 1.28 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | Baseline | 97.3 percent | Standard Deviation 1.28 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | 120 mins | 97.0 percent | Standard Deviation 0.93 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Oxygen Saturation | 12 mins | 98.3 percent | Standard Deviation 1.49 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Oxygen Saturation | Baseline | 98.8 percent | Standard Deviation 1.75 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Oxygen Saturation | 120 mins | 97.4 percent | Standard Deviation 1.51 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Oxygen Saturation | 12 mins | 97.9 percent | Standard Deviation 1.36 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Oxygen Saturation | Baseline | 98.3 percent | Standard Deviation 1.39 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Oxygen Saturation | 120 mins | 96.9 percent | Standard Deviation 1.64 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | 12 mins | 97.4 percent | Standard Deviation 1.3 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | Baseline | 97.3 percent | Standard Deviation 1.49 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | 120 mins | 96.0 percent | Standard Deviation 1.85 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Oxygen Saturation | 12 mins | 96.3 percent | Standard Deviation 2.19 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Oxygen Saturation | Baseline | 97.4 percent | Standard Deviation 2 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Oxygen Saturation | 120 mins | 97.5 percent | Standard Deviation 1.31 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | Baseline | 97.6 percent | Standard Deviation 1.3 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | 120 mins | 97.5 percent | Standard Deviation 1.41 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Oxygen Saturation | 12 mins | 96.4 percent | Standard Deviation 0.74 |
Secondary
Systolic Blood Pressure
Time frame: At Baseline, 12 minutes, and 120 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | 12 mins | 119.1 mmHg | Standard Deviation 12.19 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | Baseline | 113.1 mmHg | Standard Deviation 8.44 |
| Cohort A: 12-17 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | 120 mins | 120.5 mmHg | Standard Deviation 9.27 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Systolic Blood Pressure | 12 mins | 122.3 mmHg | Standard Deviation 10.89 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Systolic Blood Pressure | Baseline | 122.5 mmHg | Standard Deviation 11.41 |
| Cohort A: 12-17 Years Med Dose (200 uL Kovacaine Mist) | Systolic Blood Pressure | 120 mins | 120.1 mmHg | Standard Deviation 10.32 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Systolic Blood Pressure | 12 mins | 121.0 mmHg | Standard Deviation 21.21 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Systolic Blood Pressure | Baseline | 115.4 mmHg | Standard Deviation 10.06 |
| Cohort A: 12-17 High Dose (400uL Kovacaine Mist) | Systolic Blood Pressure | 120 mins | 116.4 mmHg | Standard Deviation 9.62 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | 12 mins | 105.5 mmHg | Standard Deviation 13.32 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | Baseline | 111.3 mmHg | Standard Deviation 7.59 |
| Cohort B: 7-11 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | 120 mins | 106.3 mmHg | Standard Deviation 8.84 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Systolic Blood Pressure | 12 mins | 109.9 mmHg | Standard Deviation 6.53 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Systolic Blood Pressure | Baseline | 106.5 mmHg | Standard Deviation 9.35 |
| Cohort B: 7-11 Years Med Dose (200 uL Kovacaine Mist) | Systolic Blood Pressure | 120 mins | 102.3 mmHg | Standard Deviation 9.81 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | Baseline | 97.8 mmHg | Standard Deviation 8.36 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | 120 mins | 101.9 mmHg | Standard Deviation 16.16 |
| Cohort C: 3-6 Years Low Dose (120uL Kovacaine Mist) | Systolic Blood Pressure | 12 mins | 101.9 mmHg | Standard Deviation 10.19 |