Phase 4 N=20 Treatment

Buffered Local Anesthetic

Dental Pain

Bottom Line

View on ClinicalTrials.gov: NCT05757648 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcome: Primary: Pain Score as Measured by the Behavior Pain Scale — 2.24; 2.61 score on a scale — p=0.005

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Non-buffered Anesthetic (Drug); Buffered Anesthetic (Drug); Onset (Device)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: University Hospitals Cleveland Medical Center
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Score as Measured by the Behavior Pain Scale	2.24; 2.61	0.005 sig
PRIMARY Change in Heart Rate as Measured by as Measured by Medical Record	91; 95	0.775
PRIMARY Change in Diastolic Blood Pressure as Measured by Medical Record	52; 53.2	0.682
PRIMARY Change in Systolic Blood Pressure as Measured by Medical Record	91; 95	—
PRIMARY Change in CO2 Level as Measured by Medical Record	39.7; 40.3; 40.9; 40.2	—
PRIMARY Change in Oxygen Saturation Level as Measured by Medical Record	99.3; 99.0; 99.4; 99.2	—

Summary

The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.

Eligibility Criteria

Inclusion Criteria

Healthy children or children with mild controlled systemic illness
Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration

Exclusion Criteria

Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
Antibiotic premedication requirement
History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
Has signs of dental pain, odontogenic abscess or facial cellulitis
Allergy to local anesthetics or sulfites

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05757648). 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.