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

Not Applicable

Withdrawn

• Conditions: Pediatric Dentistry
• Interventions: Device: Onset Mixing Pen by Onpharma

• Registration Number: NCT01883232
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-05-17
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Study Start: 2013-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-16
• Last Update Posted: 2015-12-17
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Onset Mixing Pen by Onpharma	Onset Mixing Pen by Onpharma	Sodium Bicarbonate 8.4% mixed with the onset mixing pen

Primary Outcome Measures

Name	Time	Method
Time it takes for buffered injection to take effect measured in minutes.	5 minutes	minutes for the analgesic effect to take place.
Change in pain rating using the Wong-Baker scale	During injection (about 5 minutes)	By buffering the lidocaine/epinephrine injection, one should see a decrease in in pain during the administration of the anesthetic.

Trial Locations

Locations (1)

Children's Hospital Colorado Dental Clinic; 🇺🇸 Aurora, Colorado, United States