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

Primary Purpose

Pain, Procedural

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Procedural

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Local anesthesia

Standard care

Arm Description

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

Participants will receive standard care general anesthesia

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Change in heart rate
Heart rate will be assessed throughout the surgical procedure using standard finger pulse oximeter
Change in respiratory rate
Respiratory rate will be assessed throughout the surgical procedure by the anesthesia machine via sampling line.
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
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

Full Information

First Posted
July 31, 2020
Last Updated
March 16, 2023
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04500158
Brief Title
The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort
Official Title
The Effect of Local Anesthesia When Used in Dental Restorative Cases Under General Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Procedural

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local anesthesia
Arm Type
Experimental
Arm Description
Participants will receive local anesthesia in addition to the standard care general anesthesia
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Participants will receive standard care general anesthesia
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
2% Lidocaine with 1:100,000 epi
Primary Outcome Measure Information:
Title
Change in pain
Description
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.
Time Frame
from baseline to post survey, up to 3 hours
Title
Post operative pain
Description
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
Time Frame
in the evening of the day of surgery, up to 10 hours
Secondary Outcome Measure Information:
Title
Change in heart rate
Description
Heart rate will be assessed throughout the surgical procedure using standard finger pulse oximeter
Time Frame
baseline to completion of surgery, up to 3 hours
Title
Change in respiratory rate
Description
Respiratory rate will be assessed throughout the surgical procedure by the anesthesia machine via sampling line.
Time Frame
baseline to completion of surgery, up to 3 hours
Title
Change in end tidal carbon dioxide
Description
The end tidal carbon dioxide will be assessed throughout the surgical procedure by the anesthesia machine via sampling line
Time Frame
baseline to post surgery, up to 3 hours
Title
Number of participants requiring anesthesiologist intervention
Description
Whether intervention by the anesthesiologist is needed during surgery will be coded as 0 for no and 1 for yes
Time Frame
baseline to post surgery, up to 3 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Bortell, DDS
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayakumar Jayaraman, BDS
Phone
804-828-2362
Email
jayaramanj@vcu.edu
First Name & Middle Initial & Last Name & Degree
Tiffany Williams, DDS
Phone
8048282362
Email
twilliams25@vcu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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