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Local Anesthesia with Lidocaine for Procedural Pain
Phase 3
Recruiting
Led By Elizabeth Bortell, DDS
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pediatric patients undergoing GA for dental restorative work at Virginia Commonwealth University Children's Hospital of Richmond Pavilion and Brook Road Centers
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up in the evening of the day of surgery, up to 10 hours
Awards & highlights
Study Summary
This trial is testing if local anesthetic improves dental surgery outcomes when done under general anesthesia.
Who is the study for?
This trial is for pediatric patients who need dental restorative work under general anesthesia at specific centers in Virginia. It's not for children with sensory or behavioral issues, or those needing tooth extractions or surgery.Check my eligibility
What is being tested?
The study is testing the use of Lidocaine, a local anesthetic, during dental procedures performed under general anesthesia. The goal is to see if it helps control vital signs during surgery and improves comfort afterwards.See study design
What are the potential side effects?
Lidocaine may cause side effects like numbness around the area where it's applied, mild discomfort upon injection, and in rare cases allergic reactions or changes in heart rate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is having dental work under general anesthesia at VCU Children's Hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ in the evening of the day of surgery, up to 10 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~in the evening of the day of surgery, up to 10 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain
Post operative pain
Secondary outcome measures
Change in end tidal carbon dioxide
Change in heart rate
Change in respiratory rate
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Local anesthesiaExperimental Treatment1 Intervention
Participants will receive local anesthesia in addition to the standard care general anesthesia
Group II: Standard careActive Control1 Intervention
Participants will receive standard care general anesthesia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
2011
Completed Phase 4
~1360
Find a Location
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
691 Previous Clinical Trials
22,884,693 Total Patients Enrolled
Elizabeth Bortell, DDSPrincipal InvestigatorVirginia Commonwealth University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need teeth pulled or surgery.My child has sensory or behavioral issues.My child is having dental work under general anesthesia at VCU Children's Hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Local anesthesia
- Group 2: Standard care
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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