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The Efficacy of Analgesic Buffering With Sodium Bicarbonate for the Pediatric Dental Patient

NCT ID: NCT01883232

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-02-29

Brief Summary

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As a dentist, administering anesthetic to patients, especially children, proves to be one of the most difficult parts of a procedure. Pain is one of the most common symptom in dentistry, and a serious concern for the dentist. The pain of the local anesthetic injection has several causes. Of the many reasons for pain at the site of injection, the acidity of the solution is thought to be most important. This study will be measuring the effects of adding sodium bicarbonate (buffer) to local anesthetic during dental procedures. This is commonly used in medical applications but is not widely used in the dental setting. Using this biochemistry and human physiology, one can predict when buffering the lidocaine injection, a quicker response in analgesia and a decrease in pain during administration. I will be measuring the effect using several measuring devices to gauge if buffering the local anesthetic will benefit the pediatric dental patient by reducing the time it takes for the analgesic effect as well as decreasing the pain during administration. Along with time, I will be using the Wong-Baker Scale to assess the pain. This scale is standard protocol for assessing pain in the pediatric population. The pediatric dental population has aversions to dental procedures because of the associated pain produced from most procedures. If limiting the time it takes for the analgesic to take effect and decrease the pain altogether, the pediatric patient will be less likely to skip treatment therefore, increase dental health.

Detailed Description

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Conditions

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Pediatric Dentistry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2% lidocaine with 1:100,000 epinephrine

2% lidocaine with 1:100,000 epinephrine

Group Type ACTIVE_COMPARATOR

2% lidocaine with 1:100,000 epinephrine

Intervention Type DEVICE

2% lidocaine with 1:100,000 epinephrine administered with a syringe prior to the procedure

Onset Mixing Pen by Onpharma

Sodium Bicarbonate 8.4% mixed with the onset mixing pen

Group Type EXPERIMENTAL

Onset Mixing Pen by Onpharma

Intervention Type DEVICE

Sodium Bicarbonate 8.4%

Interventions

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Onset Mixing Pen by Onpharma

Sodium Bicarbonate 8.4%

Intervention Type DEVICE

2% lidocaine with 1:100,000 epinephrine

2% lidocaine with 1:100,000 epinephrine administered with a syringe prior to the procedure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Current patients of Children's Hospital Colorado Dental Clinic
* Existence of carious primary molars necessitating administration of an anesthetic agent
* No history of post traumatic stress disorder or specific phobia related to a dental setting
* No allergic reaction to lidocaine
* Patient's between the ages of 5 to 12.

Exclusion Criteria

* Allergies to local anesthetics or sulfites
* History of significant medical conditions
* Taking any medications that may affect anesthetic assessment
* Active sites of pathology in areas if injection
* Outside the age range of 5 -12.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie Esker, DMD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado Dental Clinic

Locations

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Children's Hospital Colorado Dental Clinic

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Kashyap VM, Desai R, Reddy PB, Menon S. Effect of alkalinisation of lignocaine for intraoral nerve block on pain during injection, and speed of onset of anaesthesia. Br J Oral Maxillofac Surg. 2011 Dec;49(8):e72-5. doi: 10.1016/j.bjoms.2011.04.068. Epub 2011 May 18.

Reference Type RESULT
PMID: 21592633 (View on PubMed)

Grassick P. The fear behind the fear: a case study of apparent simple injection phobia. J Behav Ther Exp Psychiatry. 1990 Dec;21(4):281-7. doi: 10.1016/0005-7916(90)90030-o.

Reference Type RESULT
PMID: 1982735 (View on PubMed)

Arndt KA, Burton C, Noe JM. Minimizing the pain of local anesthesia. Plast Reconstr Surg. 1983 Nov;72(5):676-9. doi: 10.1097/00006534-198311000-00017.

Reference Type RESULT
PMID: 6622575 (View on PubMed)

Meit SS, Yasek V, Shannon CK, Hickman D, Williams D. Techniques for reducing anesthetic injection pain: an interdisciplinary survey of knowledge and application. J Am Dent Assoc. 2004 Sep;135(9):1243-50. doi: 10.14219/jada.archive.2004.0399.

Reference Type RESULT
PMID: 15493388 (View on PubMed)

Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.

Reference Type RESULT
PMID: 16384767 (View on PubMed)

Reed KL, Malamed SF, Fonner AM. Local anesthesia part 2: technical considerations. Anesth Prog. 2012 Fall;59(3):127-36; quiz 137. doi: 10.2344/0003-3006-59.3.127.

Reference Type RESULT
PMID: 23050753 (View on PubMed)

Malamed SF, Falkel M. Advances in local anesthetics: pH buffering and dissolved CO2. Dent Today. 2012 May;31(5):88-93; quiz 94-5. No abstract available.

Reference Type RESULT
PMID: 22650087 (View on PubMed)

Christoph RA, Buchanan L, Begalla K, Schwartz S. Pain reduction in local anesthetic administration through pH buffering. Ann Emerg Med. 1988 Feb;17(2):117-20. doi: 10.1016/s0196-0644(88)80293-2.

Reference Type RESULT
PMID: 2827545 (View on PubMed)

Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40.

Reference Type RESULT
PMID: 18784857 (View on PubMed)

Other Identifiers

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13-0298

Identifier Type: -

Identifier Source: org_study_id