Buffered Lidocaine in the Pediatric Dental Patient

March 14, 2023 updated by: Geisinger Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Xylocaine
Experimental: 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
Drug: 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.
Other Names:
  • Xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Pain Perception
Time Frame: 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.
Within 1 minute of anesthetic administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of Soft Tissue Anesthesia
Time Frame: Time of injection to 4 minutes post-injection (tested in 15 second intervals).
Time to gum numbness, assessed using periodontal probe and patient response.
Time of injection to 4 minutes post-injection (tested in 15 second intervals).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider Reported Pain Perception
Time Frame: 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.
During local anesthesia administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Gayatri Malik, DMD, PhD, Geisinger Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

December 17, 2021

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

August 9, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Dentistry

Clinical Trials on Buffered Lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lithuania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe