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Clinical trial

The Effect of Local Anesthesia When Used in Dental Restorative Cases Under General Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort

ID
Name
HM20018316
Description
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.
Trial arms
Trial start
2020-11-03
Estimated PCD
2024-02-28
Trial end
2024-02-28
Status
Completed
Phase
Early phase I
Treatment
Lidocaine
2% Lidocaine with 1:100,000 epi
Arms:
Local anesthesia
Size
59
Primary endpoint
Change in pain
from baseline to post survey, up to 3 hours
Post operative pain
in the evening of the day of surgery, up to 10 hours
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 59, 'type': 'ACTUAL'}}
Updated at
2024-03-29

1 organization

1 product

2 indications

Organization
Virginia Commonwealth University
Product
Lidocaine
Indication
Pain
Indication
Procedural