Phase 3 N=59 Randomized Triple-blind Supportive Care

The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort

Pain, Procedural

Bottom Line

View on ClinicalTrials.gov: NCT04500158 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Post Operative Pain — 13; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lidocaine (Drug)
Age: Pediatric
Sex: All
Sponsor: Virginia Commonwealth University
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Post Operative Pain	13; 10	—
SECONDARY Number of Teeth Treated	8.6; 7.4	—
SECONDARY Procedure Time	85.4; 70.6	—
SECONDARY PACU Time	39.8; 39.9	—

Summary

The purpose of this study is to compare patient responses during and after surgery when local anesthetic is used for dental treatment under general anesthesia (GA) and when it is not used.

Eligibility Criteria

Inclusion Criteria

Pediatric patients undergoing GA for dental restorative work at Virginia Commonwealth University Children's Hospital of Richmond Pavilion and Brook Road Centers

Exclusion Criteria

Children with any sensory or behavioral issues
Patients requiring extractions or surgical procedures

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04500158). 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.