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Buffered Lidocaine in the Pediatric Dental Patient

Pain Perception Associated With Administration of Buffered Lidocaine Versus Conventional Lidocaine in the Pediatric Dental Patient

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04055116
Enrollment
64
Registered
2019-08-13
Start date
2019-11-11
Completion date
2022-03-01
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Dentistry

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

Geisinger Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

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

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Patient Reported Pain PerceptionWithin 1 minute of anesthetic administrationWong-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

MeasureTime frameDescription
Onset of Soft Tissue AnesthesiaTime of injection to 4 minutes post-injection (tested in 15 second intervals).Time to gum numbness, assessed using periodontal probe and patient response.

Other

MeasureTime frameDescription
Provider Reported Pain PerceptionDuring local anesthesia administrationFaces, 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

ArmCount
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
Total55

Withdrawals & dropouts

PeriodReasonFG000FG001
First InterventionPhysician Decision27

Baseline characteristics

CharacteristicUnbuffered Lidocaine, Then Buffered LidocaineBuffered Lidocaine, Then Unbuffered LidocaineTotal
Age, Categorical
<=18 years
28 Participants27 Participants55 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
28 participants27 participants55 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 55
other
Total, other adverse events
0 / 550 / 55
serious
Total, serious adverse events
0 / 550 / 55

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Unbuffered LidocainePatient Reported Pain Perception3.52 units on a scaleStandard Deviation 3.21
Buffered LidocainePatient Reported Pain Perception3.48 units on a scaleStandard Deviation 3.19
Secondary

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).

ArmMeasureValue (MEAN)Dispersion
Unbuffered LidocaineOnset of Soft Tissue Anesthesia102.21 secondsStandard Deviation 142.44
Buffered LidocaineOnset of Soft Tissue Anesthesia81.07 secondsStandard Deviation 70.6
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
Unbuffered LidocaineProvider Reported Pain Perception1.88 units on a scaleStandard Deviation 2.4
Buffered LidocaineProvider Reported Pain Perception2.43 units on a scaleStandard Deviation 2.71

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026