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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local anesthesia | Experimental | Participants will receive local anesthesia in addition to the standard care general anesthesia |
|
| Standard care | No Intervention | Participants will receive standard care general anesthesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 2% Lidocaine with 1:100,000 epi |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | in the evening of the day of surgery, up to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Teeth Treated | Will report the mean and standard deviation of number of teeth treated | start of procedure to end of procedure, the intraoperative time frme |
| Procedure Time | Will report the mean and standard deviation of the procedure time |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Bortell, DDS | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Local Anesthesia | Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi |
| FG001 | Standard Care | Participants will receive standard care general anesthesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Number of subjects that completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Local Anesthesia | Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi |
| BG001 | Standard Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Number of parents that completed the parents post operative pain measure | Posted | Count of Participants | Participants | in the evening of the day of surgery, up to 10 hours |
|
Subjects were followed for the day of the procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Local Anesthesia | Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caroline Carrico | Virginia Commonwealth University | (804) 828-8328 | ckcarrico@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2022 | Aug 19, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 1, 2022 | Aug 19, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| start of procedure to end of procedure, minutes |
| PACU Time | Will report the mean and standard deviation of time after the procedure to through time in the post-anesthesia care unit | time from after procedure to through time in the post-anesthesia care unit in minutes |
Participants will receive standard care general anesthesia
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Standard Care |
Participants will receive standard care general anesthesia |
|
|
| Secondary | Number of Teeth Treated | Will report the mean and standard deviation of number of teeth treated | Number of subjects that completed the study. | Posted | Mean | Standard Deviation | teeth treated | start of procedure to end of procedure, the intraoperative time frme |
|
|
|
| Secondary | Procedure Time | Will report the mean and standard deviation of the procedure time | Number of subjects that completed the study. | Posted | Mean | Standard Deviation | procedure time in minutes | start of procedure to end of procedure, minutes |
|
|
|
| Secondary | PACU Time | Will report the mean and standard deviation of time after the procedure to through time in the post-anesthesia care unit | Number of subjects that completed the study | Posted | Mean | Standard Deviation | Time in minutes | time from after procedure to through time in the post-anesthesia care unit in minutes |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Standard Care | Participants will receive standard care general anesthesia | 0 | 16 | 0 | 16 | 0 | 16 |
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| Aniline Compounds |
| D000588 | Amines |