Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients
Condition: Pain
Intervention: Sodium bicarbonate; Lidocaine
Intervention description: 8.4% neutralizing solution; 2% lidocaine with 1:100,000 ppm epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine; Anesthetics, Local; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 20.0
Sex: All
Minimum age: 9 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effectiveness of buffered local anesthesia
      injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine
      with sodium bicarbonate may reduce the pain of injection for both adults and children. In
      this study, the investigators will compare two local anesthetic preparations, a buffered
      anesthetic and the conventionally available anesthetic, for pain upon injection.

      Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection
      compared to the acidic alternative used in most dental offices. This can be demonstrated by
      comparing two local anesthetic preparations, a buffered anesthetic and the conventionally
      available anesthetic, for pain upon injection.
    

Eligibility criteria:

        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