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

NCT04500158 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HM20018316
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Procedural

Outcome Measures

Primary Outcomes (1)

• Post Operative Pain

  The Parent's Postoperative Pain Measure ( abbreviated: PPPM) Scale consists of 15 questions with scores ranging from 0 to 15, with one point assigned to each question answered with a "Yes" and therefore higher scores indicating worse postoperative pain. A score of 6 or greater is considered clinically significant pain which was tallied for the primary outcome measure (i..e number of participants experiencing clinically significant postoperative pain).

  in the evening of the day of surgery, up to 10 hours

Secondary Outcomes (3)

• Number of Teeth Treated

  start of procedure to end of procedure, the intraoperative time frme

• Procedure Time

  start of procedure to end of procedure, minutes

• PACU Time

  time from after procedure to through time in the post-anesthesia care unit in minutes

Study Arms (2)

Local anesthesia

EXPERIMENTAL

Participants will receive local anesthesia in addition to the standard care general anesthesia

Drug: Lidocaine

Standard care

NO INTERVENTION

Participants will receive standard care general anesthesia

Interventions

Lidocaine DRUG

2% Lidocaine with 1:100,000 epi

Local anesthesia

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pain, Procedural

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Caroline Carrico
• Organization: Virginia Commonwealth University

ckcarrico@vcu.edu

(804) 828-8328

Study Officials

• Elizabeth Bortell, DDS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 5, 2020
• Study Start: November 3, 2020
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)