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

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Procedural

Intervention / Treatment
-----------------
* Drug: Lidocaine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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