Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years
Condition: Anesthesia, Local; Pain
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): 1% Buffered Lidocaine 1:100,000 Epinephrine; 2% Unbuffered Lidocaine 1:100,000 Epinephrine
Intervention type(s): Drug; Drug
Intervention description(s): A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.; A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
Other intervention name(s): Xylocaine; Xylocaine
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: Healthy pediatric volunteers