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

NCT ID: NCT03562481

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-24
• Study Completion Date: 2019-06-30

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. Pain experience on injection, time to onset following the administration, and time to recovery [subjective]

2. Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia [objective]

Null Hypotheses:

1. 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.

2. No differences exist in peak blood lidocaine levels, pain on injection, time to lip numbness, and duration of anesthesia between the two drug formulations.

Randomized subjects will be injected orally for bottom jaw anesthesia, with 3cc of buffered 1% lidocaine (30mg) 1:100,000 epinephrine or 3cc unbuffered of 2% lidocaine (60mg) 1:100,000 epinephrine. The injectable volume of the buffered formulation will include 0.3cc of 8.4% sodium bicarbonate.

One faculty member in the Department of Pediatric Dentistry at the University of North Carolina (UNC) School of Dentistry will administer the drugs in the Pediatric Dentistry clinic. The same clinician will administer injection to the same subjects at both visits. Clinicians and subjects will not know which drug formulation is given at which appointment.

A clinician will measure the level of discomfort on injection, how long it takes for the lip to be numb, how long it takes for the first molar tooth in that area to be numb, how long it takes the local anesthetic to wear off, and how much of the anesthetic is in the blood.

Conditions

Anesthesia, Local; Pain

Study Design

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

Study Groups

Buffered Anesthetic, then Unbuffered Anesthetic

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.

Group Type: EXPERIMENTAL

1% Buffered Lidocaine 1:100,000 Epinephrine

Intervention Type: DRUG

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

2% Unbuffered Lidocaine 1:100,000 Epinephrine

Intervention Type: DRUG

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

Unbuffered Anesthetic, then Buffered Anesthetic

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.

Group Type: EXPERIMENTAL

1% Buffered Lidocaine 1:100,000 Epinephrine

Intervention Type: DRUG

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

2% Unbuffered Lidocaine 1:100,000 Epinephrine

Intervention Type: DRUG

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

Interventions

1% Buffered Lidocaine 1:100,000 Epinephrine

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

Intervention Type: DRUG

2% Unbuffered Lidocaine 1:100,000 Epinephrine

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

Intervention Type: DRUG

Other Intervention Names

Xylocaine; Xylocaine

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Y Lee, DDS,MPH,PhD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill School of Dentistry, Pediatric Dentistry

Locations

UNC School of Dentistry

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-3106

Identifier Type: -

Identifier Source: org_study_id