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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01883232
Enrollment
0
Registered
2013-06-21
Start date
2013-08-31
Completion date
2016-02-29
Last updated
2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Dentistry

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.

Interventions

DEVICEOnset Mixing Pen by Onpharma

Sodium Bicarbonate 8.4%

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

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026