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

NCT01622296 | Completed Phase 4 Results DMC

• 1 other identifier: 1107214
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment

  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

Study Arms (2)

Sodium Bicarbonate with Lidocaine

ACTIVE COMPARATOR

Drug: Sodium bicarbonate

Lidocaine with no buffer

PLACEBO COMPARATOR

Drug: Lidocaine

Interventions

Sodium bicarbonate DRUG

8.4% neutralizing solution

Also known as: Sodium Bicarbonate Inj., 8.4% USP Neutralizing Additive Solution (NDC Code 509-100-03)

Sodium Bicarbonate with Lidocaine

Lidocaine DRUG

2% lidocaine with 1:100,000 ppm epinephrine

Also known as: 2% lidocaine (Brand name: Xylocaine) with 1:100,000 ppm epinephrine, part of the amide family of local anesthetics

Lidocaine with no buffer

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (3)

• Milgrom P, Coldwell SE, Getz T, Weinstein P, Ramsay DS. Four dimensions of fear of dental injections. J Am Dent Assoc. 1997 Jun;128(6):756-66. doi: 10.14219/jada.archive.1997.0301.

  PMID: 9188235 BACKGROUND

• Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.

  PMID: 21154371 BACKGROUND

• von Baeyer CL. Children's self-report of pain intensity: what we know, where we are headed. Pain Res Manag. 2009 Jan-Feb;14(1):39-45. doi: 10.1155/2009/259759.

  PMID: 19262915 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sodium Bicarbonate; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The variation of VAS scores was found to be larger than that used in the sample size calculation; thus, the study was underpowered to reach statistical significance.

Results Point of Contact

• Title: Dr. Susan Parveen Tavana
• Organization: UCSF School of Dentistry

susan.tavana@ucsf.edu

415-476-1891

Study Officials

• Susan Tavana, DDS

  University of Caifornia, San Francisco

  PRINCIPAL INVESTIGATOR

• Peter Loomer, DDS, PhD

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 19, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: March 17, 2014
• Results First Posted: March 17, 2014

Record last verified: 2014-02

Locations

US (1)