Pain, Procedural
Conditions
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.
Interventions
DRUGLidocaine
2% Lidocaine with 1:100,000 epi
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain | in the evening of the day of surgery, up to 10 hours | The Parent's Postoperative Pain Measure ( abbreviated: PPPM) Scale consists of 15 questions with scores ranging from 0 to 15, with one point assigned to each question answered with a Yes and therefore higher scores indicating worse postoperative pain. A score of 6 or greater is considered clinically significant pain which was tallied for the primary outcome measure (i..e number of participants experiencing clinically significant postoperative pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PACU Time | time from after procedure to through time in the post-anesthesia care unit in minutes | Will report the mean and standard deviation of time after the procedure to through time in the post-anesthesia care unit |
| Number of Teeth Treated | start of procedure to end of procedure, the intraoperative time frme | Will report the mean and standard deviation of number of teeth treated |
| Procedure Time | start of procedure to end of procedure, minutes | Will report the mean and standard deviation of the procedure time |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Local Anesthesia Participants will receive local anesthesia in addition to the standard care general anesthesia
Lidocaine: 2% Lidocaine with 1:100,000 epi | 15 |
| Standard Care Participants will receive standard care general anesthesia | 16 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 17 | 11 |
Baseline characteristics
| Characteristic | Local Anesthesia | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 1 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 15 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
Primary
Post Operative Pain
The Parent's Postoperative Pain Measure ( abbreviated: PPPM) Scale consists of 15 questions with scores ranging from 0 to 15, with one point assigned to each question answered with a Yes and therefore higher scores indicating worse postoperative pain. A score of 6 or greater is considered clinically significant pain which was tallied for the primary outcome measure (i..e number of participants experiencing clinically significant postoperative pain).
Time frame: in the evening of the day of surgery, up to 10 hours
Population: Number of parents that completed the parents post operative pain measure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Anesthesia | Post Operative Pain | 13 Participants |
| Standard Care | Post Operative Pain | 10 Participants |
Secondary
Number of Teeth Treated
Will report the mean and standard deviation of number of teeth treated
Time frame: start of procedure to end of procedure, the intraoperative time frme
Population: Number of subjects that completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia | Number of Teeth Treated | 8.6 teeth treated | Standard Deviation 3.4 |
| Standard Care | Number of Teeth Treated | 7.4 teeth treated | Standard Deviation 3.4 |
Secondary
PACU Time
Will report the mean and standard deviation of time after the procedure to through time in the post-anesthesia care unit
Time frame: time from after procedure to through time in the post-anesthesia care unit in minutes
Population: Number of subjects that completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia | PACU Time | 39.8 Time in minutes | Standard Deviation 11.6 |
| Standard Care | PACU Time | 39.9 Time in minutes | Standard Deviation 9.3 |
Secondary
Procedure Time
Will report the mean and standard deviation of the procedure time
Time frame: start of procedure to end of procedure, minutes
Population: Number of subjects that completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthesia | Procedure Time | 85.4 procedure time in minutes | Standard Deviation 32.8 |
| Standard Care | Procedure Time | 70.6 procedure time in minutes | Standard Deviation 29 |