Pediatric Dentistry
Conditions
Brief summary
Local anesthetic buffered with sodium bicarbonate has been suggested to reduce pain, discomfort and onset time of local anesthesia on injection into tissue, compared to non-buffered solutions. Buffered local anesthesia has been used in medicine, however intraoral injections with buffered solutions are less common in dentistry. Most research has focused on adult perception of pain on administration of buffered local anesthetic. There have been few studies and inconclusive evidence to show that buffered lidocaine reduces the perception of pain on administration in children. The purpose of this interventional study is to assess pain reduction and onset time on injection of buffered 2% lidocaine with 1:100,000 epinephrine in children.
Detailed description
This project's primary aim is to evaluate pain perception in buffered vs non-buffered local anesthesia in children undergoing routine dental treatment. The secondary aim is to evaluate if the buffered solution results in a faster onset of local anesthesia compared to conventional solution. Through a well-designed study, we hope to contribute to the profession's understanding of advanced local anesthesia techniques in children. This study has been designed as a longitudinal, double blind, crossover study. Specifically, a split mouth design will be implemented to investigate if there is a significant difference in pain perception between administering buffered local anesthesia versus conventional local anesthesia in a pediatric patient. We will also investigate time of onset of local anesthesia and compare buffered to non-buffered solutions. Patients will be treated by a single pediatric dental resident while being overseen by a board-certified attending pediatric dentist at Geisinger Medical Center (GMC). This study will be implemented upon receiving Institutional Review Board (IRB) approval. The population of interest includes healthy children aged 4-17yo. Children selected for this study will be assessed using the American Society of Anesthesiologists (ASA) physical status classification system. In an effort to control for confounding variables, only healthy children classified as ASA I or ASA II will be included in this study. Children selected for this study will have been determined to require treatment on two occasions on opposite sides of the mouth. Patients will not be excluded if they develop localized infection requiring treatment without systemic antibiotics, however, they will only remain in the study if both sides requiring treatment are either free of infection or if both sides have a localized pain or infection requiring treatment without systemic antibiotics. Patients must have no allergy to lidocaine or history of adverse reactions to epinephrine, no history of hyperthyroidism, and no significant cardiovascular disease per recommendations for administration of local anesthetic according to the American Academy of Pediatric Dentistry (AAPD).12 Buffered lidocaine has been approved for use in patients for medical and dental procedures. There is no additional cost to the patient for receiving buffered versus non-buffered solution. Prior to initiation of treatment, patients will rate their pain using the Wong-Baker FACES Pain Scale in order to establish a baseline and to help eliminate confounding variables. Also before treatment, a tooth that will be anesthetized will be probed with a periodontal probe to establish a baseline perception of this sensation without local anesthesia. Upon probing without local anesthesia, the patient will ask if they feel a pinch, in order to establish this baseline. When asked if they feel a pinch, patients will respond with a yes or no answer, which will be recorded. Patients will be asked to rate their pain related to administration of solution (the second prompt) once the injection is finished. Patients will be observed during injection and assessed by the operator using the Faces, Legs, Arms, Crying Consolability (FLACC) scale. Immediately after local anesthesia, patients will be asked to rate the pain of injection of solution using the Wong-Baker FACES Pain Scale. After administration of local anesthetic solution, the onset time of soft tissue anesthesia will be measured by using a periodontal probe in the sulcus of the anesthetized tooth or a single tooth in the anesthetized quadrant. This probing will be initiated 15 seconds after initial injection of anesthetic solution and will be repeated at 15 second intervals until local anesthesia is achieved. After each probing attempt, patients will be asked if they felt a pinch. Once the patient answers no, the time of onset, in number of seconds to achieve anesthesia from injection to a no answer, will be recorded. Data will be analyzed using t-tests to examine treatment differences. Given patients will be treated with both methods, they will act as their own controls and paired t-tests will be utilized. If covariates are identified (e.g., patients' baseline pain perception), Repeated measure ANOVAs will be utilized with patients as within-subject variable and the patient experience as the outcome.
Interventions
Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used.
Sponsors
Study design
Masking description
Designated Investigators will randomize participants and prepare the local anesthetic with or without buffered solution. The anesthetic will then be given to the care provider at time of procedure. The care provider and participant will not know if the buffered solution has been added or not.
Intervention model description
This study has been designed as a longitudinal, double blind, crossover study. Specifically, a split mouth design will be implemented to investigate if there is a significant difference in pain perception between administering buffered local anesthesia versus conventional local anesthesia in a pediatric patient.
Eligibility
Inclusion criteria
1. Patients requiring restorative or surgical dental treatment on two occasions on opposite sides of the mouth; either both maxillary or both mandibular quadrant/sextant involving comparable teeth/areas 2. Patients able to undergo dental treatment in the dental clinic without general anesthesia, sedation, or anxiolysis 3. Patients 4-17 years of age 4. Patients classified as ASA I or ASA II 5. Patients of parents who can read, write and give consent in English
Exclusion criteria
1. Patients with allergy to local anesthetic 2. Patients who are pregnant or nursing 3. Patients with cardiac concerns or contraindications to epinephrine 4. Patients unable to undergo dental treatment in the clinic for behavior or medical reasons 5. Patients requiring anxiolysis, sedation, or general anesthesia 6. Patients unable to keep dental appointments or return for dental appointments 7. Patients who do not meet inclusion criteria 8. Patients who experience a missed block (IANB) during injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain Perception | Within 1 minute of anesthetic administration | Wong-Baker FACES Pain Rating Scale responses after buffered and non-buffered lidocaine. Range: 0 - No Hurt to 10 - Hurts Worst (higher numbers indicate higher levels of pain). There are no sub-scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Soft Tissue Anesthesia | Time of injection to 4 minutes post-injection (tested in 15 second intervals). | Time to gum numbness, assessed using periodontal probe and patient response. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Provider Reported Pain Perception | During local anesthesia administration | Faces, Legs, Arms, Crying Consolability (FLACC) Behavioral Pain Scale. This scale helps clinicians assess patients' pain based on behavioral observations. Range: 0 - 2 per category (higher number indicates more observed agitation/potential pain). A score is given in each of the five categories (Faces, Legs, Arms, Crying, Consolability). The sum of these scores provides the Assessment of Behavioral Score (range: 0 - 10) with higher scores indicating higher levels of pain. |
Countries
United States
Participant flow
Pre-assignment details
Number of participants was high than the protocol enrollment number due to patients starting study but being removed by physician if patients could not follow study procedure.
Participants by arm
| Arm | Count |
|---|---|
| Unbuffered Lidocaine, Then Buffered Lidocaine Subjects will receive an injection of non-buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.
Buffered Lidocaine: Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used. | 28 |
| Buffered Lidocaine, Then Unbuffered Lidocaine Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion.Subjects will receive an injection of this buffered 2% lidocaine with 1:100,000 epinephrine on one occasion; they will be randomized to this group. After a minimum of one week, subjects will receive the alternate solution.
We will use 8.4% Sodium Bicarbonate manufactured by Hospira, Inc. Lake Forest, IL
Buffered Lidocaine: Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used. | 27 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Physician Decision | 2 | 7 |
Baseline characteristics
| Characteristic | Unbuffered Lidocaine, Then Buffered Lidocaine | Buffered Lidocaine, Then Unbuffered Lidocaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 28 Participants | 27 Participants | 55 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 28 participants | 27 participants | 55 participants |
| Sex: Female, Male Female | — | — | 0 Participants |
| Sex: Female, Male Male | — | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Patient Reported Pain Perception
Wong-Baker FACES Pain Rating Scale responses after buffered and non-buffered lidocaine. Range: 0 - No Hurt to 10 - Hurts Worst (higher numbers indicate higher levels of pain). There are no sub-scores.
Time frame: Within 1 minute of anesthetic administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unbuffered Lidocaine | Patient Reported Pain Perception | 3.52 units on a scale | Standard Deviation 3.21 |
| Buffered Lidocaine | Patient Reported Pain Perception | 3.48 units on a scale | Standard Deviation 3.19 |
Onset of Soft Tissue Anesthesia
Time to gum numbness, assessed using periodontal probe and patient response.
Time frame: Time of injection to 4 minutes post-injection (tested in 15 second intervals).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unbuffered Lidocaine | Onset of Soft Tissue Anesthesia | 102.21 seconds | Standard Deviation 142.44 |
| Buffered Lidocaine | Onset of Soft Tissue Anesthesia | 81.07 seconds | Standard Deviation 70.6 |
Provider Reported Pain Perception
Faces, Legs, Arms, Crying Consolability (FLACC) Behavioral Pain Scale. This scale helps clinicians assess patients' pain based on behavioral observations. Range: 0 - 2 per category (higher number indicates more observed agitation/potential pain). A score is given in each of the five categories (Faces, Legs, Arms, Crying, Consolability). The sum of these scores provides the Assessment of Behavioral Score (range: 0 - 10) with higher scores indicating higher levels of pain.
Time frame: During local anesthesia administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unbuffered Lidocaine | Provider Reported Pain Perception | 1.88 units on a scale | Standard Deviation 2.4 |
| Buffered Lidocaine | Provider Reported Pain Perception | 2.43 units on a scale | Standard Deviation 2.71 |