The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Change in pain [from baseline to post survey, up to 3 hours]
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 [in the evening of the day of surgery, up to 10 hours]
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 [baseline to completion of surgery, up to 3 hours]
Heart rate will be assessed throughout the surgical procedure using standard finger pulse oximeter
- Change in respiratory rate [baseline to completion of surgery, up to 3 hours]
Respiratory rate will be assessed throughout the surgical procedure by the anesthesia machine via sampling line.
- Change in end tidal carbon dioxide [baseline to post surgery, up to 3 hours]
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 [baseline to post surgery, up to 3 hours]
Whether intervention by the anesthesiologist is needed during surgery will be coded as 0 for no and 1 for yes
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Elizabeth Bortell, DDS, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HM20018316