Clinical trial NCT03562481: Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years
Official title: Pilot Study: Comparison of Buffered 1% vs. Unbuffered 2% Lidocaine in Pediatric Subjects; Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Local
Pain
Keywords: Healthy pediatric volunteers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 26
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.


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)

Primary outcomes:
measure: Mean Pain Scores Following Injection
timeFrame: Within 10 minutes of injection
measure: Mean Time to Lower Lip Numbness Following Injection
timeFrame: Up to 30 minutes following injection
measure: Average Serum Lidocaine Concentration at 15 Minutes Post Injection
timeFrame: One blood draw taken 15 minutes following injection
measure: Mean Time to Baseline Lip Sensation
timeFrame: Within 24 hours following injection
measure: Number of Participants Who Respond to Cold Stimulus (Positive/Negative) Prior to Injection
timeFrame: 5 minutes prior to injection
measure: Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 30 Minutes Following Injection
timeFrame: 30 minutes following injection
measure: Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 60 Minutes Following Injection
timeFrame: 60 minutes following injection
measure: Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 90 Minutes Following Injection
timeFrame: 90 minutes following injection
measure: Number of Participants Who Respond to Cold Stimulus (Positive/Negative) 120 Minutes Following Injection
timeFrame: 120 minutes following injection
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC School of Dentistry
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill School of Dentistry, Pediatric Dentistry
name: Jessica Y Lee, DDS,MPH,PhD
role: PRINCIPAL_INVESTIGATOR
References: