Phase 4 N=64 Randomized Triple-blind Treatment

Buffered Lidocaine in the Pediatric Dental Patient

Pediatric Dentistry

Bottom Line

View on ClinicalTrials.gov: NCT04055116 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Patient Reported Pain Perception — 3.52; 3.48 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Buffered Lidocaine (Drug)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Geisinger Clinic
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Reported Pain Perception	3.52; 3.48	—
SECONDARY Onset of Soft Tissue Anesthesia	102.21; 81.07	—

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.

Eligibility Criteria

Inclusion Criteria

Patients requiring restorative or surgical dental treatment on two occasions on opposite sides of the mouth; either both maxillary or both mandibular quadrant/sextant involving comparable teeth/areas
Patients able to undergo dental treatment in the dental clinic without general anesthesia, sedation, or anxiolysis
Patients 4-17 years of age
Patients classified as ASA I or ASA II
Patients of parents who can read, write and give consent in English

Exclusion Criteria

Patients with allergy to local anesthetic
Patients who are pregnant or nursing
Patients with cardiac concerns or contraindications to epinephrine
Patients unable to undergo dental treatment in the clinic for behavior or medical reasons
Patients requiring anxiolysis, sedation, or general anesthesia
Patients unable to keep dental appointments or return for dental appointments
Patients who do not meet inclusion criteria
Patients who experience a missed block (IANB) during injection

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04055116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.