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

Study Overview
=================
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.

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

Conditions
-----------------
Pediatric Dentistry

Intervention / Treatment
-----------------
* Device: Onset Mixing Pen by Onpharma
* Device: 2% lidocaine with 1:100,000 epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2% lidocaine with 1:100,000 epinephrine<br>2% lidocaine with 1:100,000 epinephrine | Device: 2% lidocaine with 1:100,000 epinephrine<br>* 2% lidocaine with 1:100,000 epinephrine administered with a syringe prior to the procedure<br>|
| Experimental: Onset Mixing Pen by Onpharma<br>Sodium Bicarbonate 8.4% mixed with the onset mixing pen | Device: Onset Mixing Pen by Onpharma<br>* Sodium Bicarbonate 8.4%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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