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

University of Colorado Denver (CU Denver)

Status: Withdrawn

Conditions: Pediatric Dentistry

Treatments: Device: 2% lidocaine with 1:100,000 epinephrine; Device: Onset Mixing Pen by Onpharma

Study type: Interventional

Funder types: Other

Identifiers

NCT01883232

13-0298

Details and patient eligibility

About

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.

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups

2% lidocaine with 1:100,000 epinephrine

Active Comparator group

Description:

2% lidocaine with 1:100,000 epinephrine

Treatment:

Device: 2% lidocaine with 1:100,000 epinephrine

Onset Mixing Pen by Onpharma

Experimental group

Description:

Sodium Bicarbonate 8.4% mixed with the onset mixing pen

Treatment:

Device: Onset Mixing Pen by Onpharma