Buffered Local Anesthetic

University Hospitals Cleveland Medical Center20 enrolled

Overview

The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dental Pain

Interventions

Non-buffered AnestheticDRUG

non-buffered LA, 2% lidocaine with epinephrine 1:100,000

Buffered AnestheticDRUG

A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.

OnsetDEVICE

The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy children or children with mild controlled systemic illness * Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration Exclusion Criteria: * Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases * Antibiotic premedication requirement * History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment * Has signs of dental pain, odontogenic abscess or facial cellulitis * Allergy to local anesthetics or sulfites

Locations (2)

Dental Clinic of Rainbow Center for Women and Children

Cleveland, Ohio, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Pain Score as Measured by the Behavior Pain Scale

The BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures.

Time frame: Up to 10 minutes

Change in Heart Rate as Measured by as Measured by Medical Record