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

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.