Trial Outcomes & Findings for Buffered Local Anesthetic (NCT NCT05757648)
NCT ID: NCT05757648
Last Updated: 2024-07-17
Results Overview
The BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Up to 10 minutes
Results posted on
2024-07-17
Participant Flow
Unit of analysis: Mouth Side
Participant milestones
| Measure |
All Study Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Overall Study
STARTED
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20 40
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Overall Study
COMPLETED
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20 40
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Overall Study
NOT COMPLETED
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0 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Buffered Anesthetic Side/Non-buffered Anesthetic Side
n=20 Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Age, Continuous
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4.6 years
STANDARD_DEVIATION 1.1 • n=20 Participants
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Sex: Female, Male
Female
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12 Participants
n=20 Participants
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Sex: Female, Male
Male
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8 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Up to 10 minutesThe BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures.
Outcome measures
| Measure |
Buffered Anesthetic Side/Non-buffered Anesthetic Side
n=20 Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Pain Score as Measured by the Behavior Pain Scale
Buffered Anesthetic Side
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2.24 score on a scale
Interval 2.06 to 2.42
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Pain Score as Measured by the Behavior Pain Scale
Non-Buffered Anesthetic Side
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2.61 score on a scale
Interval 2.42 to 2.79
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PRIMARY outcome
Timeframe: Baseline, Up to 10 minutesOutcome measures
| Measure |
Buffered Anesthetic Side/Non-buffered Anesthetic Side
n=20 Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Change in Heart Rate as Measured by as Measured by Medical Record
Baseline
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91 Beats per minute
Interval 86.6 to 95.4
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Change in Heart Rate as Measured by as Measured by Medical Record
10 minutes
|
95 Beats per minute
Interval 90.6 to 99.4
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PRIMARY outcome
Timeframe: Baseline, Up to 10 minutesOutcome measures
| Measure |
Buffered Anesthetic Side/Non-buffered Anesthetic Side
n=20 Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Change in Diastolic Blood Pressure as Measured by Medical Record
Baseline
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52 mmHG
Interval 47.4 to 56.6
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Change in Diastolic Blood Pressure as Measured by Medical Record
10 minutes
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53.2 mmHG
Interval 48.5 to 57.8
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PRIMARY outcome
Timeframe: Baseline, Up to 10 minutesOutcome measures
| Measure |
Buffered Anesthetic Side/Non-buffered Anesthetic Side
n=20 Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Change in Systolic Blood Pressure as Measured by Medical Record
Baseline
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91 mmHG
Interval 86.6 to 95.4
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Change in Systolic Blood Pressure as Measured by Medical Record
10 minutes
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95 mmHG
Interval 90.6 to 99.4
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PRIMARY outcome
Timeframe: Baseline, Up to 10 minutesOutcome measures
| Measure |
Buffered Anesthetic Side/Non-buffered Anesthetic Side
n=20 Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Change in CO2 Level as Measured by Medical Record
Baseline Buffered Side
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39.7 mEq/L
Interval 37.2 to 42.1
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Change in CO2 Level as Measured by Medical Record
Up to 10 mins Buffered Side
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40.3 mEq/L
Interval 37.8 to 42.8
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Change in CO2 Level as Measured by Medical Record
Baseline Non-Buffered Side
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40.9 mEq/L
Interval 38.4 to 43.5
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Change in CO2 Level as Measured by Medical Record
Up to 10 mins Non-Buffered Side
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40.2 mEq/L
Interval 37.7 to 42.7
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PRIMARY outcome
Timeframe: Baseline, Up to 10 minutesOutcome measures
| Measure |
Buffered Anesthetic Side/Non-buffered Anesthetic Side
n=20 Participants
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered Anesthetic: A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
Onset: The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
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|---|---|
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Change in Oxygen Saturation Level as Measured by Medical Record
Baseline Buffered Side
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99.3 percentage of oxygen saturation
Interval 98.6 to 100.0
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Change in Oxygen Saturation Level as Measured by Medical Record
Up to 10 mins Buffered Side
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99.0 percentage of oxygen saturation
Interval 98.3 to 99.6
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Change in Oxygen Saturation Level as Measured by Medical Record
Baseline Non-Buffered Side
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99.4 percentage of oxygen saturation
Interval 98.7 to 100.0
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Change in Oxygen Saturation Level as Measured by Medical Record
Up to 10 mins Non-Buffered Side
|
99.2 percentage of oxygen saturation
Interval 98.6 to 99.9
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Adverse Events
Buffered Anesthetic Side/Non-buffered Anesthetic Side
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ying An
University Hospitals Cleveland Medical Center
Phone: (216)368-3277
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place