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

Pain Clinical Trial

Official title:

Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562481
• Other study ID #: 16-3106
• Status: Completed
• Phase: Phase 4
• Start date: July 24, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	UNC School of Dentistry	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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