Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years

NCT03562481 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-3106
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Local anesthesia is an integral part of clinical pediatric dental practice, but it has challenges. It can be uncomfortable for children, and the risk of adverse events limits how much is used. Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection. These findings have not been replicated and validated among pediatric populations, creating a gap in the knowledge base. To address this knowledge gap and contribute to the evidence base on safety and efficacy of local anesthesia in pediatric dentistry, this investigation proposes to compare the anesthetic effects of buffered 1% lidocaine with those of unbuffered 2%, among children. The specific aims of this investigation are to determine differences between buffered 1% and unbuffered 2% lidocaine (both with 1:100,000 epinephrine) used for inferior alveolar nerve block (IAN) anesthesia, in the following domains:

1. 1.Pain experience on injection, time to onset following the administration, and time to recovery \[subjective\]
2. 2.Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia \[objective\]
3. 3.No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1% Lidocaine with 1:100,000 epinephrine as compared to unbuffered 2% Lidocaine with 1:100,000 epinephrine.
4. 4.No differences exist in peak blood lidocaine levels, pain on injection, time to lip numbness, and duration of anesthesia between the two drug formulations.

Conditions

Anesthesia, Local; Pain

Keywords

Healthy pediatric volunteers

Outcome Measures

Primary Outcomes (9)

• Mean Pain Scores Following Injection

  Perceived pain on injection, self-reported verbally using a Likert scale from 1-10, with lower numbers corresponding to less pain (1 = "no pain," 10 = "worst pain imaginable"). Lower scores reflect a lesser degree of pain.

  Within 10 minutes of injection

• Mean Time to Lower Lip Numbness Following Injection

  Time in minutes beginning immediately following injection to patient-reported lip numbness

  Up to 30 minutes following injection

• Average Serum Lidocaine Concentration at 15 Minutes Post Injection

  Blood Lidocaine Level (mcg/mL) as measured in 10cc venous blood, taken 15 minutes following injection. Blood assayed for serum lidocaine levels with a Sciex TripleTOF liquid chromatography- mass spectrometry (LC-MS) equipped with a C18 Hypersil (10mm x 2.1mm, 3.0μm).

  One blood draw taken 15 minutes following injection

• Mean Time to Baseline Lip Sensation

  Response in minutes from injection to when lip is no longer numb, as self reported by patient.

  Within 24 hours following injection

• Number of Participants Who Respond to Cold Stimulus (Positive/Negative) Prior to Injection

  Response to experiencing sensation to cold stimulus on permanent molar tooth prior to injection

  5 minutes prior to injection

• Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 30 Minutes Following Injection

  Response to experiencing sensation to cold stimulus on permanent molar tooth 30 minutes following injection

  30 minutes following injection

• Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 60 Minutes Following Injection

  Response to experiencing sensation to cold stimulus on permanent molar tooth 60 minutes following injection

  60 minutes following injection

• Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 90 Minutes Following Injection

  Response to experiencing sensation to cold stimulus on permanent molar tooth 90 minutes following injection

  90 minutes following injection

• Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 120 Minutes Following Injection

  Response to experiencing sensation to cold stimulus on permanent molar tooth 120 minutes following injection

  120 minutes following injection

Study Arms (2)

Buffered Anesthetic, then Unbuffered Anesthetic

EXPERIMENTAL

Subjects randomized to Buffered Anesthetic, then Unbuffered Anesthetic will first receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine.

Drug: 1% Buffered Lidocaine 1:100,000 Epinephrine; Drug: 2% Unbuffered Lidocaine 1:100,000 Epinephrine

Unbuffered Anesthetic, then Buffered Anesthetic

EXPERIMENTAL

Subjects randomized to Unbuffered Anesthetic, then Buffered Anesthetic will first receive an injection with 2% Unbuffered Lidocaine 1:100,000 Epinephrine. After one week minimum washout period, subjects will then receive an injection with 1% Buffered Lidocaine 1:100,000 Epinephrine.

Drug: 1% Buffered Lidocaine 1:100,000 Epinephrine; Drug: 2% Unbuffered Lidocaine 1:100,000 Epinephrine

Interventions

1% Buffered Lidocaine 1:100,000 Epinephrine DRUG

A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.

Also known as: Xylocaine

Buffered Anesthetic, then Unbuffered Anesthetic; Unbuffered Anesthetic, then Buffered Anesthetic

2% Unbuffered Lidocaine 1:100,000 Epinephrine DRUG

A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.

Also known as: Xylocaine

Buffered Anesthetic, then Unbuffered Anesthetic; Unbuffered Anesthetic, then Buffered Anesthetic

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 10-12 years
• American Society of Anesthesiologists (ASA) Class I (Healthy)
• Body Weight: the Interquartile Range (IQR) 33-60Kg for subject ages
• Have ability to speak and read English
• Willingness to participate in two sessions
• No history of adverse reaction to dental anesthetic
• Have bilateral, disease/symptom-free mandibular first molars present

You may not qualify if:

• Allergy to lidocaine class of anesthetic drugs
• Local anesthetic drug use in past week
• Current symptomatic teeth or oral mucosa
• ASA II or above (including asthma)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC School of Dentistry

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Epinephrine; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds

Results Point of Contact

• Title: Jessica Lee, DDS, MPH, PhD
• Organization: University of North Carolina at Chapel Hill

jessica_lee@unc.edu

9195373955

Study Officials

• Jessica Y Lee, DDS,MPH,PhD

  UNC-Chapel Hill School of Dentistry, Pediatric Dentistry

  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, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study subjects will serve as their own controls in this crossover AB/BA study design which is uniform within sequences (groups, i.e. AB/BA, of order of drug formulation administration), uniform within periods (equal time between administration of alternating drug formulations), and balanced (equal number of subjects within each study arm). The randomization will be performed to the type of drug given first, using a balanced randomization (half subjects buffered, half unbuffered) implemented with SAS software routines. During the first session, each subject will receive an IAN block with the first randomly assigned anesthetic formulation using the Halstead technique. At least a week later, substantially longer than the elimination half-life of the drug lidocaine (1.5-2hr), local anesthetic injections will be done using the alternate local anesthetic formulation.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 19, 2018
• Study Start: July 24, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: June 25, 2020
• Results First Posted: June 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: 9 to 36 months following publication
• Access Criteria: Investigators who propose to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and must execute a data use/sharing agreement with UNC.

Locations

US (1)