CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
Buffered Lidocainedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04055116
NCT04055116Phase 4Completed

Pain Perception Associated With Administration of Buffered Lidocaine Versus Conventional Lidocaine in the Pediatric Dental Patient

Geisinger Clinic·interventional·Posted Aug 13, 2019·Updated Apr 7, 2023

In Brief

A Phase 4 clinical trial evaluating Buffered Lidocaine for Pediatric Dentistry. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedAug 13, 2019
Enrollment StartNov 11, 2019
Primary CompletionDec 17, 2021
Study CompletionMar 1, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.9 years ago

Interventions

Buffered Lidocainedrug

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.