Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients

Local anesthesia is an essential procedure in the comprehensive treatment of pediatric
patients. In the treatment of subjects with dental disease and infection, local anesthesia
is commonly required when performing operative procedures. The use of local anesthesia
serves two main purposes: (i) enables the patient to remain free of discomfort during the
sometimes painful procedure and (ii) permits the practitioner to complete the procedure
without fear of hurting the patient which might otherwise impede the practitioner's ability
to provide comprehensive care. However, patients are often fearful of local anesthesia
because traditional preparations of local anesthesia are acidic and can be painful. Thus,
an important advance in the areas of subject management and pain control during operative
procedures would be a preparation of local anesthesia that significantly reduced the pain
upon injection. A 2010 Cochrane Review found that adjusting the pH of lidocaine with sodium
bicarbonate reduced the pain of injection for both adults and children. In this study, we
will compare two local anesthetic preparations, a buffered anesthetic and the conventionally
available anesthetic, for pain upon injection.

The study will test a local anesthetic buffering system, the Onset system, an FDA Class 1
compounding device manufactured by Onpharma Inc. It is a simple and portable local
anesthesia buffering system that compounds anesthetic solution and 8.4% sodium bicarbonate
neutralizing additive solution in a precise manner that brings the anesthetic solution up to
human physiologic pH. Commercially available local anesthetics have a low pH to allow for
prolonged shelf life, and to keep the anesthetic molecules in solution. The combination of a
buffering sodium bicarbonate agent and local anesthetic has been reported to result in
pain-free injections for both adults and children. The neutralizing additive solution is a
sterile, nonpyrogenic, solution of sodium bicarbonate (NaHCO3) in water. pH is adjusted with
carbon dioxide. Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code
509-100-03) and Lidocaine w/ Epinephrine are compatible. Sodium bicarbonate is used in
medicine and dentistry as regularly as saline, and pre-dates the FDA. It is commercially
available and currently being used by health professionals in the U.S.A.

The local anesthetic used in the study will be 2% lidocaine with 1:100,000 ppm epinephrine,
part of the amide family of local anesthetics. It has been widely used in dentistry and
medicine and has long-standing proven records of safety.

Inclusion Criteria:

- Give written, informed consent (both the subject and the legal guardian)

- Be 9-12 years of age

- Be able to comprehend the visual analog scale (instructions given to ascertain this)

- Be able to comprehend the verbal rating scale (instructions given to ascertain this)

- In the opinion of the investigator, be a subject who can be expected to comply with
the protocol

- Present moderate mandibular dental disease bilaterally

- Have 4 to 7 natural teeth (with at least one posterior tooth) present in each
mandibular quadrant with moderate dental disease on at least one tooth

- Be willing to attend the clinic for 3 or more appointments

Exclusion Criteria:

- Antibiotic premedication requirement

- A history of allergy, sensitivity, or any other form of adverse reactions to local
anesthetics of the amide type, or epinephrine

- A history of specific systemic illness that would preclude administration of a local
anesthetic or vasoconstrictor (epinephrine) (e.g. liver , renal, cardiovascular
diseases, blood dyscrasias, psychiatric disorders, etc.)

- A history of systemic illness that would interfere with healing response (e.g. liver
disease, blood dyscrasias, uncontrolled diabetes, etc.)

- Current systemic medication that interferes with healing response

- Current systemic medication which contraindicates the use of local anesthetics or
epinephrine

- Pregnant or lactating females (contradicts the use of local anesthetic in
non-emergency type dental procedures)

- Current alcohol or drug abuse

- Received an anesthetic, analgesic or sedative within 24 hours prior to the therapy
appointments

- Acute infections or conditions in the oral cavity requiring immediate treatment

- Participation in a clinical study of an investigational drug within the previous 4
weeks

- Previous enrollment in the present study