Pain Perception Associated With Administration of Buffered Lidocaine Versus Conventional Lidocaine in the Pediatric Dental Patient
Phase: PHASE4
Conditions: Pediatric Dentistry
Sponsor: Geisinger Clinic

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Pain Perception and Onset Associated with Administration of Buffered 
Lidocaine Versus Conventional Lidocaine in the Pediatric Dental Patient
Research Protocol – IRB 2019-0408
Principal Investigator: 
Gayatri Malik, DMD, PhD
570-246-2811
100 N. Academy Ave
Danville, Pa 17822
Investigators: 
Lacey N Williams, DMD
570-246-2811
100 N. Academy Ave
Danville, Pa 17822
Natalie Stinton, DMD 
570-246-2811
155 South Arch St.
Suite A
Milton, PA 17847 
Jessica Lee, DMD
570-246-2811
100 N. Academy Ave
Danville, Pa 17822
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Table of Contents
1 Abbreviations Used in the Protocol
2 Abstract
3 Background and Significance
4 Hypothesis and Specific Aims
4.1 Hypothesis
4.2 Specific Aim 1
4.3 Specific Aim 2
4.4 Specific Aim 3
4.5 Specific Aim 4
5 Study Design
5.1 Description
5.2 Study Population
5.2.1 Approximate Number of Subjects
5.2.2 Inclusion Criteria
5.2.3 Exclusion Criteria
5.3 Recruitment
5.4 Study Duration
5.4.1 Approximate Duration of Subject Participation
5.4.2 Approximate Duration of Study
5.5 Statistics
5.5.1 Statistical Analysis Plan
5.5.2 Statistical Power and Sample Size Considerations
6 Data Management
7 References
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1 ABBREVIATIONS USED IN THE PROTOCOL 
Abbreviation
Term
IANB
Inferior Alveolar Nerve Block
GMC
Geisinger Medical Center
IRB
Institutional Review Board
ASA
American Society of Anesthesiologists 
AAPD
American Academy of Pediatric Dentistry
MRN
Medical Record Number
PA
Pennsylvania
FLACC
Faces, Legs, Arms, Crying Consolability
 
2 ABSTRACT
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. 
3 BACKGROUND AND SIGNIFICANCE
Local anesthesia is a necessary component of dental treatment that aids in establishing patient 
comfort and reduction of anxiety. However, a local anesthesia injection is often uncomfortable 
and unpleasant. Injection of local anesthesia can elicit a painful or burning sensation. In children, 
profound anesthesia and ease of administration can help establish and maintain positive dental 
experiences and also reduce anxiety in the dental setting. The injection is not only uncomfortable 
during the penetration of the needle through the epidermis, but also during injection of acidic 
solution into the tissue. 
Commercially available local anesthetics are often prepared with hydrochloric acid to increase 
their solubility and stability1. These local anesthetics range in pH from 3.5 to 5.5 and are 
significantly lower than the physiological pH of 7.35.1 The acidity of a traditionally prepared 
local anesthetic solution has been shown to contribute to pain during injection of local anesthetic 
and also to an increased onset time of local anesthesia2. Buffering the traditional local anesthetic 
solution to a pH value closer to physiological pH has been done to aid in pain reduction 
associated with injection of solution2. Based on the Hederson-Hasselbach equation, it has been 
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shown that neutralizing the solution of local anesthesia can reduce the pain perception associated 
with administration of local anesthesia and decrease the onset time3. With an increase in pH of 
solution, more free base is available to cross the nerve sheath, reducing the onset of action3.
Medicine has used buffered local anesthetic solutions with success and the literature reflects this 
adaptation into clinical practice.3,4,5,6 Previous studies have investigated the difference in onset 
and the reduction of pain in administration of buffered lidocaine vs traditional lidocaine in both 
children and adults. There have been fewer studies investigating the perception of discomfort 
during injection and the difference in anesthesia onset time in children compared to adult 
subjects. The literature has shown varied results and conclusions in both children and adult study 
populations. Some of these studies have found a significant difference in onset time and 
perceived pain reduction with buffered solution compared to standard solution, while others have 
failed to find significant differences.1,7,8,9,10,11 
This project’s primary aim is to evaluate pain perception in buffered vs non-buffered local 
anesthetic administration 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. 
4. HYPOTHESIS AND SPECIFIC AIMS
4.1 HYPOTHESIS: 
4.1.1 Null Hypothesis: There will be no significant difference between buffered 
local anesthesia vs conventional anesthesia in pain reduction. 
4.1.2 Null Hypothesis: There will be no significant reduction in time between 
buffered local anesthesia vs conventional anesthesia achieving soft tissue 
anesthesia.  
4.1.3 Hypothesis: There will be a statistically significant reduction in pain on 
intraoral administration of buffered 2% lidocaine with 1:100,000 epinephrine 
compared to non-buffered 2% lidocaine w/1:100,000 epinephrine in children. 
4.1.4 Hypothesis: Buffered 2% lidocaine with 1:100,000 epinephrine will have a 
statically significant faster onset of soft tissue anesthesia compared to non-
buffered 2% lidocaine w/1:100,000 epinephrine in children
4.2 SPECIFIC AIM 1:
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To determine if buffering 2% lidocaine with 1:100,000 epinephrine reduces discomfort 
experienced on injection compared to non-buffered solution in children with a split 
mouth design
4.3 SPECIFIC AIM 2:
To compare infiltration vs inferior alveolar nerve block (IANB) in experience of pain 
reduction with buffered 2% lidocaine with 1:100,000 epinephrine on injection in children 
among different groups; patients will either receive two or more infiltrations or two or 
more IANBs. 
4.4 SPECIFIC AIM 3: 
To determine if buffering 2% lidocaine with 1:100,000 epinephrine reduces onset time of 
local anesthesia compared to non-buffered solution in children
4.5 SPECIFIC AIM 4:
To compare onset time of local anesthetic via infiltration versus IANB using buffered 2% 
lidocaine with 1:100,000 epinephrine in children
5. STUDY DESIGN
5.1 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. 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 or 
more occasions on opposite sides of the mouth. If a patient has multiple issues on each 
side of the mouth, the patient may be asked to participate in the study procedures for a 
second time. This could result in seeing the patient for 4 separate visits. 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 
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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. 
Patients will be examined by the pediatric dental resident under supervision of the 
attending pediatric dentist. At the time of examination, patients that meet the inclusion 
criteria (see section 5.2.2 below) will be offered to enroll in this research study. Each 
patient will consent for treatment via a parent or legal guardian. The parent or legal 
guardian and the provider will review the inclusion and exclusion criteria, risks and 
benefits to participation in this study, and general information about the timeline and 
clinical expectations of the patient. The consent process will be completed by the 
pediatric dental resident under supervision of the attending pediatric dentist. The patient’s 
parent or legal guardian will be given a chance to ask questions during the consent 
process. Parents and legal guardians will be given the option to have their child included 
in the study or to have their child proceed with traditional treatment with non-buffered 
local anesthesia. Study participants are those that will be consented to receive a blinded 
solution of either buffered or non-buffered solution over two or more appointments. 
There will be no financial compensation or incentive to participate in this study. There is 
no advantage or disadvantage for patients undergoing treatment in this study as compared 
to patients not included in the study. Compared to patient’s not included in the study, 
there is no additional risk with patients electing to be removed from the study or for 
patients who fail to complete treatment. In addition to obtaining parental or guardian 
consent, patients aged 15-17 years of age will sign assent. Study participants will receive 
a copy of this consent/assent form.
Following patient selection (based on the inclusion and exclusion criteria listed below in 
section 5.2.2), and consent, each patient will be assigned number as they are added into 
the study. This number will be sequential; e.g. the first patient will be assigned a number 
of ‘1,’ and the second patient will be assigned a number of ‘2.’ Patients will be added to 
the study at time of consent after the initial examination by the dental resident. 
On the day of the procedure, the side of the mouth that is treated first will be based on the 
patient’s chief complaint. If the patient does not have a chief complaint, the side of the 
mouth that is treated first will be the side of the mouth with more significant dental 
caries. The attending pediatric dentist will flip a coin to determine if the patient will 
receive the buffered or conventional local anesthetic solution during the first visit, with 
the “heads” side being assigned to the buffered solution, and the “tails” side assigned to 
the non-buffered solution. At the patient’s second visit, the alternative local anesthetic 
solution will be used, and the other side of the mouth will be treated. 
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The attending pediatric dentist will have access to a protected Excel spreadsheet 
containing information related to each patient including: patient name, medical record 
number (MRN), the patient’s number assignment (as discussed above), date of the first 
and second visit, which local anesthetic solution was administered at each visit, the local 
anesthesia technique used (infiltration vs IANB), which arch (maxilla vs mandible) was 
treated, and which side of the mouth was treated. This document will be locked and the 
operator will not have access to this spreadsheet in order to preserve the double-blind 
nature of this study.
Vasoconstrictors, like epinephrine, become unstable with an increase in pH9. Local 
anesthetic solutions with a vasoconstrictor are traditionally prepared as an acidic solution 
to extend shelf life9. Buffering our local anesthesia containing epinephrine will reduce the 
stability of solution from approximately 8-12 months to a shelf life of only seven days13. 
Although the solution has been said to be stable for a week, to ensure stability of the 
solution, and control for confounding variables, the buffered solutions will be mixed 
immediately before administering the solution. Other study designs have used this 
approach to mix the solution immediately before administration1,9. 
 
During the appointment requiring the buffered local anesthesia solution, the attending 
will prepare 1:10 dilution of sodium bicarbonate to local anesthesia. A 1.7mL vial of 
commercially available 2% lidocaine hydrochloric acid with 1:100,000 epinephrine 
(Lignospan standard, Septodont Lancaster, Pennsylvania (PA) will be used. The cartridge 
of lidocaine and the bottle of sodium bicarbonate will be wiped with an alcohol pad. 
0.17mL of 8.4 percent sodium bicarbonate will be added into the local anesthesia 
cartridge to make the final preparation. The pH of traditional 2% lidocaine with 
1:100,000 epinephrine is typically acidic to prolong shelf life; the pH is approximately 
4.5.8 The buffered solution will be tested using a pH tester (Water Quality Test Meter 
Pancellent TDS PH EC Temperature 4 in 1 Kit, Pancellent) to evaluate the pH range of 
this preparation, and to verify a value above 5.5. 
The attending will bring the cartridge of anesthetic to the operatory and load the syringe. 
The operator and patient will remain blinded to the type of local anesthesia that is used. 
For this study, if the patient requires treatment of the lower posterior teeth, a IANB will 
be the injection technique of choice. If the patient requires treatment in the posterior 
maxilla, an infiltration will be the injection technique of choice. After a period of no less 
than one week, the patient will return for a second visit. At the second visit, the solution 
of local anesthesia will be alternated, and the opposite side of the mouth will be treated. 
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 
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establish this baseline. When asked if they feel a pinch, patients will respond with a “yes” 
or “no” answer, which will be recorded.
Topical 20% benzocaine (Ultracare Oral Anesthetic Gel, Ultradent, South Jordan, Utah 
will be used on the intraoral tissue at site of injection for 5 minutes, and then the tissue 
will be injected. Patients will be informed when the tissue is pierced and again when the 
local anesthesia is being administered. Participants receiving an IANB will be injected 
with 0.85mL (50% volume of a 1.7mL carpule) of 2% lidocaine with 1:100,000 
epinephrine approximately. Patients receiving a buccal infiltration in the maxilla will 
receive 0.425mL (25% volume of a 1.7mL carpule) of solution over 15 seconds. The 
operator will aspirate prior to administration of local anesthetic solution in all cases; a 
positive aspiration will require redirection of the needle or repositioning before injection. 
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. These scales were 
selected because they are approved for use by the AAPD for children over the age of 3 
and have been used successfully in previous studies investigating pain perception in child 
subjects.7,14 
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. 
In the event of a missed block, the patient will be excluded from the study. The second 
attempt for local anesthesia will be made with the effort to achieve profound local 
anesthesia, and the technique and type of local anesthesia will not be limited to the 
techniques or anesthetic solutions described in this study. Local anesthesia techniques 
and solutions used in the event of a missed block will be within the scope of practice for a 
pediatric dental patient, however, this event will be considered a potential confounding 
variable in our research study. 
A second protected Excel spreadsheet will be used to record patient’s scores for the 
Wong-Baker FACES Pain Scale, the FLACC scale and the time of onset of local 
anesthesia. This spreadsheet will also include the patient’s name, MRN number, the side 
of the mouth that was treated, the location of the injection, the injection technique, and 
the date of each visit. This spreadsheet will be available to the operator in order to record 
the clinical outcomes related to each encounter; it will not affect the double-blind nature 
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of this study, as the operator will not know which local anesthetic preparation was used 
during each encounter.
After the first day of treatment, a “wash out” period of at least 1 week will be required 
before the patient can return for treatment on the other side of the mouth, and the 
administration of the alternate type of local anesthetic solution. Wash out periods have 
been used in many similar studies to minimize bias.1,7,11
5.2 STUDY POPULATION
5.2.1 Approximate Number of Subjects: 55
5.2.2 INCLUSION CRITERIA
1. Patients requiring restorative or surgical dental treatment on two or more 
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
5.2.3 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
5.3 RECRUITMENT
Study participants will be screened by a treating dentist from a GMC dental clinic at time 
of comprehensive oral exam or periodic oral exam. Patients may be added to the study by 
the treating dentist based on the inclusion criteria. Study participants will be recruited 
from the outpatient Foss clinic of Geisinger Medical Center in Danville, PA and from the 
outpatient Milton clinic of Geisinger Medical Center in Milton, PA. 
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Recruitment of study participants will be done by the treating pediatric dental resident or 
attending pediatric dentist at the time of exam. Patients will be recruited from the 
outpatient Foss clinic in Danville, PA and the outpatient Milton clinic in Milton, PA at 
Geisinger Medical Center.
5.4 STUDY DURATION
5.4.1 Approximate Duration of Subject Participation: 2 or more dental visits, with 
each visit lasting between 30-90 minutes
5.4.2 Approximate Duration of Study: 12 months
5.5 STATISTICS
5.5.1 Statistical Analysis Plan
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.
5.5.2 Statistical Power and Sample Size Considerations
Approximately 55 patients will be included in the study. Based on a medium 
effect size (Cohen’s d = .50) observed in similar research (Kurien, Goswami, & 
Singh, 2018), a sample of 55 patients with data from two timepoints will provide 
90% power and allow for a 20% (n = 11) rate of attrition. For analyses examining 
paired differences between lidocaine treatments, a sample of 44 will provide 
adequate power.
6. DATA MANAGEMENT
Only approved study staff will have access to data collected for this research.  Electronic data 
will be stored on Geisinger’s secure network.  Any hard copy data will be secured in a locked 
office or cabinet.  Only research team members can access the data files. Records of data 
generated in the course of the study shall be retained for at least 6 years after the study ends and 
could be used for future research studies submitted and approved by the IRB. To protect the 
double-blind design, the randomization excel sheet will only be available to the study physicians 
until the end of the study.
7. REFERENCES
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experience during inferior alveolar nerve block administration using buffered two percent 
lidocaine in children. Pediatr Dent. 2016;38(1):25-29.
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epinephrine buffered with 5% and 10% sodium bicarbonate in maxillary infiltrations. Journal of 
Endodontics. 2013;39(5):597-599. https://www.clinicalkey.com/#!/content/playContent/1-s2.0-
S0099239913001362?returnurl=null&referrer=null.
12. Council on Clinical Affairs. Use of local anesthesia for pediatric dental patients. American 
Academy of Pediatric Dentistry. 2015:199-205. 
https://www.aapd.org/globalassets/media/policies_guidelines/bp_localanesthesia.pdf.
13. Bartfield J, Homer P, Ford D, Sternklar P. Buffered lidocaine as a local anesthetic: An 
investigation of shelf life. Annals of Emergency Medicine. 1992;21(1):16-19. 
https://www.sciencedirect.com/science/article/pii/S0196064405822309.
14. Wells M, Townsend J. Managing pain and behavior guidance. In: Nowak A, Casamassimo P, 
eds. The handbook of pediatric dentistry. 5th ed. Chicago, IL: The American Academy of 
Pediatric Dentistry; 2018:243-244.
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https://wongbakerfaces.org
https://www1.health.gov.au/internet/publications/publishing.nsf/Content/triageqrg~triageqrg-
pain~triageqrg-wong
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https://www1.health.gov.au/internet/publications/publishing.nsf/Content/triageqrg~triageqrg-
pain~triageqrg-FLACC
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