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Buffered Lidocaine in the Pediatric Dental Patient

NCT04055116 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-04-07

Study results available
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Summary

Local anesthetic buffered with sodium bicarbonate has been suggested to reduce pain, discomfort and onset time of local anesthesia on injection into tissue, compared to non-buffered solutions. Buffered local anesthesia has been used in medicine, however intraoral injections with buffered solutions are less common in dentistry. Most research has focused on adult perception of pain on administration of buffered local anesthetic. There have been few studies and inconclusive evidence to show that buffered lidocaine reduces the perception of pain on administration in children. The purpose of this interventional study is to assess pain reduction and onset time on injection of buffered 2% lidocaine with 1:100,000 epinephrine in children.

Conditions

  • Pediatric Dentistry

Interventions

DRUG

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.

Sponsors & Collaborators

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Gayatri Malik, DMD, PhD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2021-12-17
Completion
2022-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04055116 on ClinicalTrials.gov