Buffered Lidocaine in the Pediatric Dental Patient
Condition: Pediatric Dentistry
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Buffered Lidocaine
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment