Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients
Condition: Pain
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Sodium bicarbonate; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): 8.4% neutralizing solution; 2% lidocaine with 1:100,000 ppm epinephrine
Other intervention name(s): Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code 509-100-03); 2% lidocaine (Brand name: Xylocaine) with 1:100,000 ppm epinephrine, part of the amide family of local anesthetics
Intervention MeSH terms: Lidocaine; Epinephrine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care