Trial Outcomes & Findings for Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years (NCT NCT03562481)
NCT ID: NCT03562481
Last Updated: 2020-06-25
Results Overview
Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = "no pain," 10 = "worst pain imaginable"). Lower scores reflect a lesser degree of pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Within 10 minutes of injection
Results posted on
2020-06-25
Participant Flow
Participant milestones
| Measure |
Sequence 1: Unbuffered Anesthetic, Then Buffered Anesthetic
Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. 1% After one week minimum washout period, subjects will then receive an injection with Buffered Lidocaine 1:100,000 Epinephrine.
|
Sequence 2: Buffered Anesthetic, Then Unbuffered Anesthetic
Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine.
|
|---|---|---|
|
First Intervention
STARTED
|
12
|
14
|
|
First Intervention
COMPLETED
|
11
|
14
|
|
First Intervention
NOT COMPLETED
|
1
|
0
|
|
Washout
STARTED
|
11
|
14
|
|
Washout
COMPLETED
|
11
|
14
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
11
|
14
|
|
Second Intervention
COMPLETED
|
11
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Unbuffered Anesthetic, Then Buffered Anesthetic
Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. 1% After one week minimum washout period, subjects will then receive an injection with Buffered Lidocaine 1:100,000 Epinephrine.
|
Sequence 2: Buffered Anesthetic, Then Unbuffered Anesthetic
Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine.
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years
Baseline characteristics by cohort
| Measure |
Sequence 1: Unbuffered Anesthetic, Then Buffered Anesthetic
n=12 Participants
Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine.
|
Sequence 2: Buffered Anesthetic, Then Unbuffered Anesthetic
n=14 Participants
Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.5 years
STANDARD_DEVIATION 0.5 • n=99 Participants
|
10.9 years
STANDARD_DEVIATION 0.9 • n=107 Participants
|
11.2 years
STANDARD_DEVIATION 0.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Response to Cold Testing
Negative Response to Cold Testing at Baseline
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Response to Cold Testing
Positive Response to Cold Testing at Baseline
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 10 minutes of injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = "no pain," 10 = "worst pain imaginable"). Lower scores reflect a lesser degree of pain.
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Mean Pain Scores Following Injection
|
3.0 score on a scale
Standard Deviation 1.9
|
3.3 score on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: Up to 30 minutes following injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Time in minutes beginning immediately following injection to patient-reported lip numbness
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Mean Time to Lower Lip Numbness Following Injection
|
3.4 minutes
Standard Deviation 1.3
|
4.4 minutes
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: One blood draw taken 15 minutes following injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Blood Lidocaine Level (mcg/mL) as measured in 10cc venous blood, taken 15 minutes following injection. Blood assayed for serum lidocaine levels with a Sciex TripleTOF liquid chromatography- mass spectrometry (LC-MS) equipped with a C18 Hypersil (10mm x 2.1mm, 3.0μm).
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Average Serum Lidocaine Concentration at 15 Minutes Post Injection
|
243.5 mcg/ml
Standard Deviation 127.9
|
600.2 mcg/ml
Standard Deviation 497.0
|
PRIMARY outcome
Timeframe: Within 24 hours following injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Response in minutes from injection to when lip is no longer numb, as self reported by patient.
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Mean Time to Baseline Lip Sensation
|
218 minutes
Standard Deviation 59.6
|
241 minutes
Standard Deviation 91.4
|
PRIMARY outcome
Timeframe: 5 minutes prior to injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Response to experiencing sensation to cold stimulus on permanent molar tooth prior to injection
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) Prior to Injection
Negative Response to Cold Testing at Baseline
|
6 Participants
|
2 Participants
|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) Prior to Injection
Positive Response to Cold Testing at Baseline
|
19 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 30 minutes following injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Response to experiencing sensation to cold stimulus on permanent molar tooth 30 minutes following injection
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 30 Minutes Following Injection
Negative Response to Cold Testing
|
17 Participants
|
18 Participants
|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 30 Minutes Following Injection
Positive Response to Cold Testing
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 60 minutes following injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Response to experiencing sensation to cold stimulus on permanent molar tooth 60 minutes following injection
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 60 Minutes Following Injection
Negative Response to Cold Testing
|
17 Participants
|
18 Participants
|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 60 Minutes Following Injection
Positive Response to Cold Testing
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 90 minutes following injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Response to experiencing sensation to cold stimulus on permanent molar tooth 90 minutes following injection
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 90 Minutes Following Injection
Negative Response to Cold Testing
|
15 Participants
|
18 Participants
|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 90 Minutes Following Injection
Positive Response to Cold Testing
|
10 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 120 minutes following injectionPopulation: One participant did not complete the second intervention and was excluded from the data analysis.
Response to experiencing sensation to cold stimulus on permanent molar tooth 120 minutes following injection
Outcome measures
| Measure |
Buffered Anesthetic
n=25 Participants
Subjects being administered the Buffered Anesthetic received an injection with 3cc 1% Buffered Lidocaine 1:100,000 Epinephrine. for a single IAN block using the Halstead technique.
1% Buffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
|
Unbuffered Anesthetic
n=25 Participants
Subjects being administered the Unbuffered Anesthetic received an injection with 3cc of 2% Unbuffered Lidocaine with 1:100,000 Epinephrine for a single IAN block using the Halstead technique.
2% Unbuffered Lidocaine 1:100,000 Epinephrine: A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
|
|---|---|---|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 120 Minutes Following Injection
Negative Response to Cold Testing
|
13 Participants
|
19 Participants
|
|
Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 120 Minutes Following Injection
Positive Response to Cold Testing
|
12 Participants
|
6 Participants
|
Adverse Events
Buffered Anesthetic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unbuffered Anesthetic
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
Jessica Lee, DDS, MPH, PhD
University of North Carolina at Chapel Hill
Phone: 9195373955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place