Trial Outcomes & Findings for Buffered Lidocaine in the Pediatric Dental Patient (NCT NCT04055116)
NCT ID: NCT04055116
Last Updated: 2023-04-07
Results Overview
Wong-Baker FACES Pain Rating Scale responses after buffered and non-buffered lidocaine. Range: 0 - No Hurt to 10 - Hurts Worst (higher numbers indicate higher levels of pain). There are no sub-scores.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
64 participants
Primary outcome timeframe
Within 1 minute of anesthetic administration
Results posted on
2023-04-07
Participant Flow
Number of participants was high than the protocol enrollment number due to patients starting study but being removed by physician if patients could not follow study procedure.
Participant milestones
| Measure |
Unbuffered Lidocaine, Then Buffered Lidocaine
Subjects who received an injection of non-buffered 2% lidocaine in the first week or after a minimum of one week of alternative treatment
|
Buffered Lidocaine, Then Unbuffered Lidocaine
Subjects who received an injection of buffered 2% lidocaine in the first week or after a minimum of one week of alternative treatment
|
|---|---|---|
|
First Intervention
STARTED
|
30
|
34
|
|
First Intervention
Recieved Intervention
|
28
|
27
|
|
First Intervention
COMPLETED
|
28
|
27
|
|
First Intervention
NOT COMPLETED
|
2
|
7
|
|
Washout (14 Days)
STARTED
|
28
|
27
|
|
Washout (14 Days)
COMPLETED
|
28
|
27
|
|
Washout (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (After 14 Days)
STARTED
|
28
|
27
|
|
Second Intervention (After 14 Days)
COMPLETED
|
28
|
27
|
|
Second Intervention (After 14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Unbuffered Lidocaine, Then Buffered Lidocaine
Subjects who received an injection of non-buffered 2% lidocaine in the first week or after a minimum of one week of alternative treatment
|
Buffered Lidocaine, Then Unbuffered Lidocaine
Subjects who received an injection of buffered 2% lidocaine in the first week or after a minimum of one week of alternative treatment
|
|---|---|---|
|
First Intervention
Physician Decision
|
2
|
7
|
Baseline Characteristics
Zero participants were analyzed because no data was collected.
Baseline characteristics by cohort
| Measure |
Unbuffered Lidocaine, Then Buffered Lidocaine
n=28 Participants
Subjects will receive an injection of non-buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.
Buffered Lidocaine: Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used.
|
Buffered Lidocaine, Then Unbuffered Lidocaine
n=27 Participants
Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion.Subjects will receive an injection of this buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.
We will use 8.4% Sodium Bicarbonate manufactured by Hospira, Inc. Lake Forest, IL
Buffered Lidocaine: Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
28 Participants
n=28 Participants
|
27 Participants
n=27 Participants
|
55 Participants
n=55 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=55 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=55 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Zero participants were analyzed because no data was collected.
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Zero participants were analyzed because no data was collected.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
27 participants
n=27 Participants
|
55 participants
n=55 Participants
|
PRIMARY outcome
Timeframe: Within 1 minute of anesthetic administrationWong-Baker FACES Pain Rating Scale responses after buffered and non-buffered lidocaine. Range: 0 - No Hurt to 10 - Hurts Worst (higher numbers indicate higher levels of pain). There are no sub-scores.
Outcome measures
| Measure |
Unbuffered Lidocaine
n=55 Participants
Subjects will receive an injection of non-buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.
|
Buffered Lidocaine
n=55 Participants
Subjects who received an injection of buffered 2% lidocaine in the first week or after a minimum of one week of alternative treatment.
|
|---|---|---|
|
Patient Reported Pain Perception
|
3.52 units on a scale
Standard Deviation 3.21
|
3.48 units on a scale
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Time of injection to 4 minutes post-injection (tested in 15 second intervals).Time to gum numbness, assessed using periodontal probe and patient response.
Outcome measures
| Measure |
Unbuffered Lidocaine
n=55 Participants
Subjects will receive an injection of non-buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.
|
Buffered Lidocaine
n=55 Participants
Subjects who received an injection of buffered 2% lidocaine in the first week or after a minimum of one week of alternative treatment.
|
|---|---|---|
|
Onset of Soft Tissue Anesthesia
|
102.21 seconds
Standard Deviation 142.44
|
81.07 seconds
Standard Deviation 70.60
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During local anesthesia administrationFaces, Legs, Arms, Crying Consolability (FLACC) Behavioral Pain Scale. This scale helps clinicians assess patients' pain based on behavioral observations. Range: 0 - 2 per category (higher number indicates more observed agitation/potential pain). A score is given in each of the five categories (Faces, Legs, Arms, Crying, Consolability). The sum of these scores provides the Assessment of Behavioral Score (range: 0 - 10) with higher scores indicating higher levels of pain.
Outcome measures
| Measure |
Unbuffered Lidocaine
n=55 Participants
Subjects will receive an injection of non-buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.
|
Buffered Lidocaine
n=55 Participants
Subjects who received an injection of buffered 2% lidocaine in the first week or after a minimum of one week of alternative treatment.
|
|---|---|---|
|
Provider Reported Pain Perception
|
1.88 units on a scale
Standard Deviation 2.40
|
2.43 units on a scale
Standard Deviation 2.71
|
Adverse Events
Unbuffered Lidocaine, Then Buffered Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buffered Lidocaine, Then Unbuffered Lidocaine
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place