Anesthesia
Conditions
Keywords
operative, dental procedure
Brief summary
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.
Detailed description
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13). The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and \>50 years).
Interventions
The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth
DRUGPlacebo
The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.
Sponsors
Triligent International
Rho, Inc.
St. Renatus, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female 18 years of age or older. * Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (anterior or premolar tooth #4 to #13) with no evidence of pulpal pathology. * Normal lip, nose, eyelid, and cheek sensation. * Able to understand and sign the study informed consent document, communicate with the Investigators, and understand and comply with the requirements of the protocol. * Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure (the treatment tooth). * Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive. * Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.
Exclusion criteria
* Inadequately controlled hypertension (blood pressure greater than 150/100 mm Hg). * Inadequately controlled active thyroid disease of any type. * Frequent nose bleeds (≥ 5 per month). * Having received dental care requiring a local anesthetic within the 24 hours preceding study entry. * 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 articaine, 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.) * Having received any investigational drug and/or participation in any clinical trial within the 30 days prior to study participation. * History of congenital or idiopathic methemoglobinemia.
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 15 minutes, +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 |
|---|---|---|
| Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) | at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used | 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. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older. |
| Number of Participants With a Heart Rate Higher Than 125 Bpm | at any time within 120 minutes following drug administration | — |
| Number of Participants With a Heart Rate Lower Than 50 Bpm | at any time within 120 minutes following drug administration | — |
| Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg | at any time within 120 minutes following drug administration | — |
| Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg | at any time within 120 minutes following study drug administration | — |
| Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg | at any time within 120 minutes following study drug administration | — |
| Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg | at any time within 120 minutes following study drug administration | — |
| Maximum Change From Baseline in Systolic Blood Pressure | from baseline to 120 minutes following drug administration | — |
| Maximum Change From Baseline in Diastolic Blood Pressure | from baseline to 120 minutes following drug administration | — |
| The Profile Over Time of Heart Rate | from baseline to 120 minutes following drug administration | — |
| Alcohol Sniff Test | administered at approximately 24 hours after drug administration | The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on a cotton ball. |
| The Profile Over Time of Systolic Blood Pressure | from baseline to 120 minutes following drug administration | — |
| The Profile Over Time of Diastolic Blood Pressure | from baseline to 120 minutes following drug administration | — |
| Maximum Change From Baseline in Heart Rate | from baseline to 120 minutes following drug administration | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | at 25 minutes, +3 minute window | A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia. |
Countries
United States
Participant flow
Recruitment details
Subjects were screened and enrolled at 3 sites in the U.S.
Participants by arm
| Arm | Count |
|---|---|
| Kovacaine Mist Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% | 100 |
| Placebo Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
Placebo | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Kovacaine Mist | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 41.6 years STANDARD_DEVIATION 13.98 | 40.3 years STANDARD_DEVIATION 15.23 | 41.2 years STANDARD_DEVIATION 14.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 7 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 43 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gender Female | 57 Participants | 25 Participants | 82 Participants |
| Gender Male | 43 Participants | 25 Participants | 68 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 4 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 16 Participants | 14 Participants | 30 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 64 Participants | 30 Participants | 94 Participants |
| Region of Enrollment United States | 100 participants | 50 participants | 150 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 83 / 100 | 15 / 50 |
| serious Total, serious adverse events | 0 / 100 | 0 / 50 |
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 15 minutes, +3 minute window
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 88 participants |
| Placebo | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 14 participants |
Secondary
Alcohol Sniff Test
The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on a cotton ball.
Time frame: administered at approximately 24 hours after drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kovacaine Mist | Alcohol Sniff Test | -0.8 cm | Standard Deviation 5.85 |
| Placebo | Alcohol Sniff Test | 1.3 cm | Standard Deviation 6.17 |
Secondary
Maximum Change From Baseline in Diastolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kovacaine Mist | Maximum Change From Baseline in Diastolic Blood Pressure | 11.1 mmHg | Standard Deviation 6.4 |
| Placebo | Maximum Change From Baseline in Diastolic Blood Pressure | 6.4 mmHg | Standard Deviation 6.53 |
Secondary
Maximum Change From Baseline in Heart Rate
Time frame: from baseline to 120 minutes following drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kovacaine Mist | Maximum Change From Baseline in Heart Rate | 5.3 bpm | Standard Deviation 7.81 |
| Placebo | Maximum Change From Baseline in Heart Rate | 5.1 bpm | Standard Deviation 9.02 |
Secondary
Maximum Change From Baseline in Systolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kovacaine Mist | Maximum Change From Baseline in Systolic Blood Pressure | 13.8 mmHg | Standard Deviation 10.18 |
| Placebo | Maximum Change From Baseline in Systolic Blood Pressure | 9.2 mmHg | Standard Deviation 10.23 |
Secondary
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)
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. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older.
Time frame: at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used
Population: Participants were only analyzed in their corresponding age group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Kovacaine Mist | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) | less or = to 50 | 87 percentage of participants |
| Kovacaine Mist | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) | greater than 50 | 90.3 percentage of participants |
| Placebo | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) | less or = to 50 | 20.6 percentage of participants |
| Placebo | Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years) | greater than 50 | 43.8 percentage of participants |
Secondary
Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg
Time frame: at any time within 120 minutes following study drug administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg | 1 participants |
| Placebo | Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg | 0 participants |
Secondary
Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg
Time frame: at any time within 120 minutes following study drug administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg | 1 participants |
| Placebo | Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg | 1 participants |
Secondary
Number of Participants With a Heart Rate Higher Than 125 Bpm
Time frame: at any time within 120 minutes following drug administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants With a Heart Rate Higher Than 125 Bpm | 0 participants |
| Placebo | Number of Participants With a Heart Rate Higher Than 125 Bpm | 0 participants |
Secondary
Number of Participants With a Heart Rate Lower Than 50 Bpm
Time frame: at any time within 120 minutes following drug administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants With a Heart Rate Lower Than 50 Bpm | 4 participants |
| Placebo | Number of Participants With a Heart Rate Lower Than 50 Bpm | 1 participants |
Secondary
Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg
Time frame: at any time within 120 minutes following study drug administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg | 1 participants |
| Placebo | Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg | 1 participants |
Secondary
Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg
Time frame: at any time within 120 minutes following drug administration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg | 5 participants |
| Placebo | Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg | 2 participants |
Secondary
The Profile Over Time of Diastolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kovacaine Mist | The Profile Over Time of Diastolic Blood Pressure | 10 mins | 78.5 mmHg | Standard Deviation 10.64 |
| Kovacaine Mist | The Profile Over Time of Diastolic Blood Pressure | 45 mins | 76.4 mmHg | Standard Deviation 10.5 |
| Kovacaine Mist | The Profile Over Time of Diastolic Blood Pressure | pre-study | 73.5 mmHg | Standard Deviation 9.37 |
| Kovacaine Mist | The Profile Over Time of Diastolic Blood Pressure | 60 mins | 76.6 mmHg | Standard Deviation 10.71 |
| Kovacaine Mist | The Profile Over Time of Diastolic Blood Pressure | 30 mins | 74.4 mmHg | Standard Deviation 9.13 |
| Kovacaine Mist | The Profile Over Time of Diastolic Blood Pressure | 120 mins | 79.3 mmHg | Standard Deviation 10.75 |
| Kovacaine Mist | The Profile Over Time of Diastolic Blood Pressure | 90 mins | 77.8 mmHg | Standard Deviation 10.53 |
| Placebo | The Profile Over Time of Diastolic Blood Pressure | 120 mins | 75.4 mmHg | Standard Deviation 10.27 |
| Placebo | The Profile Over Time of Diastolic Blood Pressure | 90 mins | 75.4 mmHg | Standard Deviation 10.07 |
| Placebo | The Profile Over Time of Diastolic Blood Pressure | pre-study | 74.7 mmHg | Standard Deviation 8.99 |
| Placebo | The Profile Over Time of Diastolic Blood Pressure | 10 mins | 75.2 mmHg | Standard Deviation 10.65 |
| Placebo | The Profile Over Time of Diastolic Blood Pressure | 30 mins | 67.0 mmHg | Standard Deviation 7 |
| Placebo | The Profile Over Time of Diastolic Blood Pressure | 45 mins | 74.7 mmHg | Standard Deviation 12.45 |
| Placebo | The Profile Over Time of Diastolic Blood Pressure | 60 mins | 76.7 mmHg | Standard Deviation 12.33 |
Secondary
The Profile Over Time of Heart Rate
Time frame: from baseline to 120 minutes following drug administration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kovacaine Mist | The Profile Over Time of Heart Rate | 30 mins | 67.5 beats per minute | Standard Deviation 10.86 |
| Kovacaine Mist | The Profile Over Time of Heart Rate | 60 mins | 65.8 beats per minute | Standard Deviation 10.26 |
| Kovacaine Mist | The Profile Over Time of Heart Rate | 10 mins | 68.0 beats per minute | Standard Deviation 10.66 |
| Kovacaine Mist | The Profile Over Time of Heart Rate | 90 mins | 65.6 beats per minute | Standard Deviation 10.27 |
| Kovacaine Mist | The Profile Over Time of Heart Rate | 45 mins | 66.4 beats per minute | Standard Deviation 10.52 |
| Kovacaine Mist | The Profile Over Time of Heart Rate | 120 mins | 65.6 beats per minute | Standard Deviation 9.65 |
| Kovacaine Mist | The Profile Over Time of Heart Rate | pre-study | 71.0 beats per minute | Standard Deviation 10.37 |
| Placebo | The Profile Over Time of Heart Rate | 120 mins | 68.9 beats per minute | Standard Deviation 10.49 |
| Placebo | The Profile Over Time of Heart Rate | pre-study | 73.6 beats per minute | Standard Deviation 10.5 |
| Placebo | The Profile Over Time of Heart Rate | 10 mins | 72.6 beats per minute | Standard Deviation 10.17 |
| Placebo | The Profile Over Time of Heart Rate | 30 mins | 66.3 beats per minute | Standard Deviation 3.21 |
| Placebo | The Profile Over Time of Heart Rate | 45 mins | 70.9 beats per minute | Standard Deviation 9.29 |
| Placebo | The Profile Over Time of Heart Rate | 60 mins | 69.2 beats per minute | Standard Deviation 9.99 |
| Placebo | The Profile Over Time of Heart Rate | 90 mins | 67.7 beats per minute | Standard Deviation 10.44 |
Secondary
The Profile Over Time of Systolic Blood Pressure
Time frame: from baseline to 120 minutes following drug administration
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kovacaine Mist | The Profile Over Time of Systolic Blood Pressure | 30 mins | 117.3 mmHg | Standard Deviation 13.54 |
| Kovacaine Mist | The Profile Over Time of Systolic Blood Pressure | 60 mins | 127.1 mmHg | Standard Deviation 16.62 |
| Kovacaine Mist | The Profile Over Time of Systolic Blood Pressure | 10 mins | 128.6 mmHg | Standard Deviation 15.2 |
| Kovacaine Mist | The Profile Over Time of Systolic Blood Pressure | 90 mins | 128.8 mmHg | Standard Deviation 16.53 |
| Kovacaine Mist | The Profile Over Time of Systolic Blood Pressure | 45 mins | 125.0 mmHg | Standard Deviation 18.47 |
| Kovacaine Mist | The Profile Over Time of Systolic Blood Pressure | 120 mins | 129.5 mmHg | Standard Deviation 17.97 |
| Kovacaine Mist | The Profile Over Time of Systolic Blood Pressure | pre-study | 123.1 mmHg | Standard Deviation 14.12 |
| Placebo | The Profile Over Time of Systolic Blood Pressure | 120 mins | 124.9 mmHg | Standard Deviation 15.54 |
| Placebo | The Profile Over Time of Systolic Blood Pressure | pre-study | 124.0 mmHg | Standard Deviation 13.7 |
| Placebo | The Profile Over Time of Systolic Blood Pressure | 10 mins | 125.4 mmHg | Standard Deviation 16.02 |
| Placebo | The Profile Over Time of Systolic Blood Pressure | 30 mins | 116.3 mmHg | Standard Deviation 10.26 |
| Placebo | The Profile Over Time of Systolic Blood Pressure | 45 mins | 124.8 mmHg | Standard Deviation 18.27 |
| Placebo | The Profile Over Time of Systolic Blood Pressure | 60 mins | 126.7 mmHg | Standard Deviation 18.79 |
| Placebo | The Profile Over Time of Systolic Blood Pressure | 90 mins | 126.1 mmHg | Standard Deviation 15.89 |
Other Pre-specified
Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia.
Time frame: at 25 minutes, +3 minute window
Population: This analysis is only of the participants who received 3 sprays. It does not include participants who only received 2 sprays.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Kovacaine Mist | Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 16 participants |
| Placebo | Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. | 0 participants |