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

NCT ID: NCT04500158

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2024-02-28

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.

Detailed Description

Local anesthesia is a widely used tool to ensure patient safety and comfort in the dental office. This is usually accomplished by administering a shot of numbing medicine (local anesthesia) in different parts of the mouth. Local anesthesia is an important tool used for care in the dental office however despite its standardized use in dental clinics use of local anesthetic is not standardized for use in dental cases under GA. In the literature there is some evidence suggesting that it has some marginal benefit for pain control short term post operatively and control of vital signs during surgery. Some evidence also suggests that due to its use there can be increase in post-operative lip chewing and cheek biting due to the numb sensation. Additionally, it has been seen that due to the numb sensation that children can be more irritable during when waking up after surgery.

The study section will have 60 participants of which one half will receive local anesthesia for restorative dental care under GA and the other half will receive conventional no anesthesia for restorative dental treatment under GA, based on random assignment (like the flip of a coin). There is an equal chance of being assigned to either group prior to the consented treatment. Before the surgery, a nurse will access the child's overall pain and comfort. The study team (faculty, anesthesiologist, and resident) will record the blood pressure, heart rate, and breathing duration throughout the procedure. After the child has completed the surgery a nurse will again access the child's overall pain and comfort. Lastly, parents will be contacted that evening of surgery by a member of the study team to check up on the child and will be asked some questions to access the child's comfort at home.

Conditions

Pain, Procedural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Local anesthesia

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

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

2% Lidocaine with 1:100,000 epi

Standard care

Participants will receive standard care general anesthesia

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lidocaine

2% Lidocaine with 1:100,000 epi

Intervention Type: DRUG

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

• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Bortell, DDS

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HM20018316

Identifier Type: -

Identifier Source: org_study_id