Clinical trial NCT04500158: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Procedural
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 59
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Post Operative Pain
timeFrame: in the evening of the day of surgery, up to 10 hours
Secondary outcomes:
measure: Number of Teeth Treated
timeFrame: start of procedure to end of procedure, the intraoperative time frme
measure: Procedure Time
timeFrame: start of procedure to end of procedure, minutes
measure: PACU Time
timeFrame: time from after procedure to through time in the post-anesthesia care unit in minutes
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Elizabeth Bortell, DDS
role: PRINCIPAL_INVESTIGATOR
References: