Trial Outcomes & Findings for Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients (NCT NCT01622296)
NCT ID: NCT01622296
Last Updated: 2014-03-17
Results Overview
Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 ("no pain") to 100 ("pain as bad as it can be").
COMPLETED
PHASE4
20 participants
immediately after anesthetic injection
2014-03-17
Participant Flow
20 healthy pediatric volunteers were recruited at one U.S. clinical site. All participants completed both study interventions.
Participant milestones
| Measure |
Lidocaine First, Then Buffered Lidocaine
lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
|
Buffered Lidocaine First, Then Lidocaine
buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
10
|
|
First Intervention
COMPLETED
|
10
|
10
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of at Least 1 Week
STARTED
|
10
|
10
|
|
Washout Period of at Least 1 Week
COMPLETED
|
10
|
10
|
|
Washout Period of at Least 1 Week
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
10
|
|
Second Intervention
COMPLETED
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients
Baseline characteristics by cohort
| Measure |
Crossover Lidocaine/Buffered Lidocaine
n=20 Participants
lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
|
|---|---|
|
Age, Continuous
|
10 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: immediately after anesthetic injectionPopulation: per protocol, in a crossover fashion, each participant received buffered lidocaine at one treatment visit and lidocaine at one treatment visit, in randomly assigned sequence.
Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 ("no pain") to 100 ("pain as bad as it can be").
Outcome measures
| Measure |
Lidocaine
n=20 Participants
2% lidocaine with 1:100,000 ppm epinephrine
|
Buffered Lidocaine
n=20 Participants
2% buffered lidocaine with 1:100,000 ppm epinephrine
|
|---|---|---|
|
Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment
Pain on inferior alveolar nerve block
|
43 units on a scale
Standard Deviation 6
|
33.1 units on a scale
Standard Deviation 5.5
|
|
Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment
Pain on long buccal nerve block
|
7.3 units on a scale
Standard Deviation 1.9
|
9.8 units on a scale
Standard Deviation 3.9
|
Adverse Events
Crossover Lidocaine/Buffered Lidocaine
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