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Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years
Phase 4 trial testing 1% Buffered Lidocaine 1:100,000 Epinephrine in Anesthesia, Local in 26 participants. Completed in 30 June 2019.
| Lead sponsor | University of North Carolina, Chapel Hill |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | other |
| Enrollment | 26 |
| Start date | 24 July 2018 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across United States |
University of North Carolina, Chapel Hill
Adults 10 to 12, any sex, with Anesthesia, Local or Pain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 3.0 | ± 1.9 |
| Unbuffered Anesthetic | 3.3 | ± 1.5 |
Time in minutes beginning immediately following injection to patient-reported lip numbness
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 3.4 | ± 1.3 |
| Unbuffered Anesthetic | 4.4 | ± 3.7 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 243.5 | ± 127.9 |
| Unbuffered Anesthetic | 600.2 | ± 497.0 |
Response in minutes from injection to when lip is no longer numb, as self reported by patient.
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 218 | ± 59.6 |
| Unbuffered Anesthetic | 241 | ± 91.4 |
Response to experiencing sensation to cold stimulus on permanent molar tooth prior to injection
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 6 | |
| Unbuffered Anesthetic | 2 | |
| Buffered Anesthetic | 19 | |
| Unbuffered Anesthetic | 23 |
Response to experiencing sensation to cold stimulus on permanent molar tooth 30 minutes following injection
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 17 | |
| Unbuffered Anesthetic | 18 | |
| Buffered Anesthetic | 8 | |
| Unbuffered Anesthetic | 7 |
Response to experiencing sensation to cold stimulus on permanent molar tooth 60 minutes following injection
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 17 | |
| Unbuffered Anesthetic | 18 | |
| Buffered Anesthetic | 8 | |
| Unbuffered Anesthetic | 7 |
Response to experiencing sensation to cold stimulus on permanent molar tooth 90 minutes following injection
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 15 | |
| Unbuffered Anesthetic | 18 | |
| Buffered Anesthetic | 10 | |
| Unbuffered Anesthetic | 7 |
Response to experiencing sensation to cold stimulus on permanent molar tooth 120 minutes following injection
| Group | Value | 95% CI |
|---|---|---|
| Buffered Anesthetic | 13 | |
| Unbuffered Anesthetic | 19 | |
| Buffered Anesthetic | 12 | |
| Unbuffered Anesthetic | 6 |
Local anesthesia is an integral part of clinical pediatric dental practice, but it has challenges. It can be uncomfortable for children, and the risk of adverse events limits how much is used. Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection. These findings have not been replicated and validated among pediatric populations, creating a gap in the knowledge base. To address this knowledge gap and contribute to the evidence base on safety and efficacy of local anesthesia in pediatric dentistry, this investigation proposes to compare the anesthetic effects of buffered 1% lidocaine with those of unbuffered 2%, among children. The specific aims of this investigation are to determine differences between buffered 1% and unbuffered 2% lidocaine (both with 1:100,000 epinephrine) used for inferior alveolar nerve block (IAN) anesthesia, in the following domains: 1. Pain experience on injection, time to onset following the administration, and time to recovery \[subjective\] 2. Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia \[objective\] Null Hypotheses: 1. No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1% Lidocaine with 1:100,000 epinephrine as compared to unbuffered 2% Lidocaine with 1:100,000 epinephrine. 2. No differences exist in peak blood lidocaine levels, pain on injection, time to lip numbness, and duration of anesthesia between the two drug formulations. Randomized subjects will be injected orally for bottom jaw anesthesia, with 3cc of buffered 1% lidocaine (30mg) 1:100,000 epinephrine or 3cc unbuffered of 2% lidocaine (60mg) 1:100,000 epinephrine. The injectable volume of the buffered formulation will include 0.3cc of 8.4% sodium bicarbonate. One faculty member in the Department of Pediatric Dentistry at the University of North Carolina (UNC) School of Dentistry will administer the drugs in the Pediatric Dentistry clinic. The same clinician will administer injection to the same subjects at both visits. Clinicians and subjects will not know which drug formulation is given at which appointment. A clinician will measure the level of discomfort on injection, how long it takes for the lip to be numb, how long it takes for the first molar tooth in that area to be numb, how long it takes the local anesthetic to wear off, and how much of the anesthetic is in the blood.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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