Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients (BufferDent)
|ClinicalTrials.gov Identifier: NCT01622296|
Recruitment Status : Completed
First Posted : June 19, 2012
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Sodium bicarbonate Drug: Lidocaine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients. A Prospective, Double-blind, Randomized, Crossover Study|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2013|
|Active Comparator: Sodium Bicarbonate with Lidocaine||
Drug: Sodium bicarbonate
8.4% neutralizing solution
Other Name: Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code 509-100-03)
|Placebo Comparator: Lidocaine with no buffer||
2% lidocaine with 1:100,000 ppm epinephrine
Other Name: 2% lidocaine (Brand name: Xylocaine) with 1:100,000 ppm epinephrine, part of the amide family of local anesthetics
- Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment [ Time Frame: immediately after anesthetic injection ]Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 ("no pain") to 100 ("pain as bad as it can be").
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622296
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Susan Tavana, DDS||University of Caifornia, San Francisco|
|Study Chair:||Peter Loomer, DDS, PhD||University of California, San Francisco|