Buffered Lidocaine in the Pediatric Dental Patient

NCT04055116 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2019-0408
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Dentistry

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 minute of anesthetic administration

Secondary Outcomes (1)

• Onset of Soft Tissue Anesthesia

  Time of injection to 4 minutes post-injection (tested in 15 second intervals).

Other Outcomes (1)

• Provider Reported Pain Perception

  During local anesthesia administration

Study Arms (2)

Unbuffered Lidocaine, then Buffered Lidocaine

EXPERIMENTAL

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

Buffered Lidocaine, then Unbuffered Lidocaine

EXPERIMENTAL

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

Interventions

Buffered Lidocaine 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.

Also known as: Xylocaine

Buffered Lidocaine, then Unbuffered Lidocaine; Unbuffered Lidocaine, then Buffered Lidocaine

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Patients able to undergo dental treatment in the dental clinic without general anesthesia, sedation, or anxiolysis
• Patients 4-17 years of age
• Patients classified as ASA I or ASA II
• Patients of parents who can read, write and give consent in English

You may not qualify if:

• Patients with allergy to local anesthetic
• Patients who are pregnant or nursing
• Patients with cardiac concerns or contraindications to epinephrine
• Patients unable to undergo dental treatment in the clinic for behavior or medical reasons
• Patients requiring anxiolysis, sedation, or general anesthesia
• Patients unable to keep dental appointments or return for dental appointments
• Patients who experience a missed block (IANB) during injection

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Related Publications (12)

• 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.

  PMID: 26892211 BACKGROUND

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

  PMID: 23544217 BACKGROUND

• 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.

  PMID: 24139250 BACKGROUND

• 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.

  PMID: 24497759 BACKGROUND

• 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.

  PMID: 21154371 BACKGROUND

• 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.

  PMID: 3034106 BACKGROUND

• 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.

  PMID: 30087760 BACKGROUND

• 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.

  PMID: 29377171 BACKGROUND

• 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.

  PMID: 26545279 BACKGROUND

• 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.

  PMID: 29984317 BACKGROUND

• 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.

  PMID: 23611375 BACKGROUND

• 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.

  PMID: 1539881 BACKGROUND

Related Links

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

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Gayatri Malik, MD
• Organization: Geisinger

gmalik1@geisinger.edu

15702716355

Study Officials

• Gayatri Malik, DMD, PhD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: November 11, 2019
• Primary Completion: December 17, 2021
• Study Completion: March 1, 2022
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)