Buffered Lidocaine in the Pediatric Dental Patient

NCT ID: NCT04055116

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2022-03-01

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.

Conditions

Pediatric Dentistry

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Buffered Lidocaine

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

Buffered Lidocaine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Xylocaine

Eligibility Criteria

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

8. Patients who experience a missed block (IANB) during injection

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gayatri Malik, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Countries

United States

References

Chopra R, Jindal G, Sachdev V, Sandhu M. Double-Blind Crossover Study to Compare Pain Experience During Inferior Alveolar Nerve Block Administration Using Buffered Two Percent Lidocaine in Children. Pediatr Dent. 2016 Jan-Feb;38(1):25-9.

Reference Type: BACKGROUND

PMID: 26892211 (View on PubMed)

Malamed SF, Falkel M. Buffered local anaesthetics: the importance of pH and CO2. SAAD Dig. 2013 Jan;29:9-17. No abstract available.

Reference Type: BACKGROUND

PMID: 23544217 (View on PubMed)

Balasco M, Drum M, Reader A, Nusstein J, Beck M. Buffered lidocaine for incision and drainage: a prospective, randomized double-blind study. J Endod. 2013 Nov;39(11):1329-34. doi: 10.1016/j.joen.2013.07.008. Epub 2013 Sep 5.

Reference Type: BACKGROUND

PMID: 24139250 (View on PubMed)

Afolabi O, Murphy A, Chung B, Lalonde DH. The effect of buffering on pain and duration of local anesthetic in the face: A double-blind, randomized controlled trial. Can J Plast Surg. 2013 Winter;21(4):209-12.

Reference Type: BACKGROUND

PMID: 24497759 (View on PubMed)

Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.

Reference Type: BACKGROUND

PMID: 21154371 (View on PubMed)

McKay W, Morris R, Mushlin P. Sodium bicarbonate attenuates pain on skin infiltration with lidocaine, with or without epinephrine. Anesth Analg. 1987 Jun;66(6):572-4. No abstract available.

Reference Type: BACKGROUND

PMID: 3034106 (View on PubMed)

Kurien RS, Goswami M, Singh S. Comparative evaluation of anesthetic efficacy of warm, buffered and conventional 2% lignocaine for the success of inferior alveolar nerve block (IANB) in mandibular primary molars: A randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2018 Spring;12(2):102-109. doi: 10.15171/joddd.2018.016. Epub 2018 Jun 20.

Reference Type: BACKGROUND

PMID: 30087760 (View on PubMed)

Aulestia-Viera PV, Braga MM, Borsatti MA. The effect of adjusting the pH of local anaesthetics in dentistry: a systematic review and meta-analysis. Int Endod J. 2018 Aug;51(8):862-876. doi: 10.1111/iej.12899. Epub 2018 Feb 21.

Reference Type: BACKGROUND

PMID: 29377171 (View on PubMed)

Comerci AW, Maller SC, Townsend RD, Teepe JD, Vandewalle KS. Effect of a new local anesthetic buffering device on pain reduction during nerve block injections. Gen Dent. 2015 Nov-Dec;63(6):74-8.

Reference Type: BACKGROUND

PMID: 26545279 (View on PubMed)

Guo J, Yin K, Roges R, Enciso R. Efficacy of sodium bicarbonate buffered versus non-buffered lidocaine with epinephrine in inferior alveolar nerve block: A meta-analysis. J Dent Anesth Pain Med. 2018 Jun;18(3):129-142. doi: 10.17245/jdapm.2018.18.3.129. Epub 2018 Jun 29.

Reference Type: BACKGROUND

PMID: 29984317 (View on PubMed)

Hobeich P, Simon S, Schneiderman E, He J. A prospective, randomized, double-blind comparison of the injection pain and anesthetic onset of 2% lidocaine with 1:100,000 epinephrine buffered with 5% and 10% sodium bicarbonate in maxillary infiltrations. J Endod. 2013 May;39(5):597-9. doi: 10.1016/j.joen.2013.01.008. Epub 2013 Mar 20.

Reference Type: BACKGROUND

PMID: 23611375 (View on PubMed)

Bartfield JM, Homer PJ, Ford DT, Sternklar P. Buffered lidocaine as a local anesthetic: an investigation of shelf life. Ann Emerg Med. 1992 Jan;21(1):16-9. doi: 10.1016/s0196-0644(05)82230-9.

Reference Type: BACKGROUND

PMID: 1539881 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.aapd.org/globalassets/media/policies_guidelines/bp_localanesthesia.pdf

Amerian Academy of Pediatric Dentistry Council on Clinical Affairs. Use of local anesthesia for pediatric denta patients.

Other Identifiers

2019-0408

Identifier Type: -

Identifier Source: org_study_id