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

February 10, 2014 updated by: University of California, San Francisco

Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients. A Prospective, Double-blind, Randomized, Crossover Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium Bicarbonate with Lidocaine
Drug: Sodium bicarbonate
8.4% neutralizing solution
Other Names:
  • Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code 509-100-03)
Placebo Comparator: Lidocaine with no buffer
Drug: Lidocaine
2% lidocaine with 1:100,000 ppm epinephrine
Other Names:
  • 2% lidocaine (Brand name: Xylocaine) with 1:100,000 ppm epinephrine, part of the amide family of local anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
immediately after anesthetic injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Susan Tavana, DDS, University of Caifornia, San Francisco
  • Study Chair: Peter Loomer, DDS, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 19, 2012

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1107214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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