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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Procedural
• Intervention / Treatment: Drug: Lidocaine

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local anesthesia; Participants will receive local anesthesia in addition to the standard care general anesthesia	Drug: Lidocaine; 2% Lidocaine with 1:100,000 epi
No Intervention: Standard care; Participants will receive standard care general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	Children will be assessed before and after surgery using the Face, Legs, Activity, Cry, Consolability pain scale (FLACC). The FLACC pain scale rates children's pain based on observations of five domains: face, legs, activity, crying behavior, and consolability. Each domain is rated from 0 to 2 and the scores are summed. The summed scores range from 0 to 10 with higher scores indicating greater discomfort or pain.	from baseline to post survey, up to 3 hours
Post operative pain	Parents will rate their child's pain using the Parent's Postoperative Pain Measure (PPPM). The PPPM is questionnaire which asks parents to indicate yes or no to 15 possible pain related behaviors. The number of yes responses are summed for a score ranging from 0 to 15 with higher scores indicating more pain	in the evening of the day of surgery, up to 10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	Heart rate will be assessed throughout the surgical procedure using standard finger pulse oximeter	baseline to completion of surgery, up to 3 hours
Change in respiratory rate	Respiratory rate will be assessed throughout the surgical procedure by the anesthesia machine via sampling line.	baseline to completion of surgery, up to 3 hours
Change in end tidal carbon dioxide	The end tidal carbon dioxide will be assessed throughout the surgical procedure by the anesthesia machine via sampling line	baseline to post surgery, up to 3 hours
Number of participants requiring anesthesiologist intervention	Whether intervention by the anesthesiologist is needed during surgery will be coded as 0 for no and 1 for yes	baseline to post surgery, up to 3 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Elizabeth Bortell, DDS, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Procedural; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: HM20018316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No