Buffered Local Anesthetic

Phase 4

Completed

Interventions: Drug: Non-buffered Anesthetic
Drug: Buffered Anesthetic
Device: Onset

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Buffered Anesthetic Side/Non-buffered Anesthetic Side	Onset	Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic. Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Buffered Anesthetic Side/Non-buffered Anesthetic Side	Buffered Anesthetic	Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic. Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Buffered Anesthetic Side/Non-buffered Anesthetic Side	Non-buffered Anesthetic	Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic. Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.

Primary Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure as Measured by Medical Record	Baseline, Up to 10 minutes
Change in Heart Rate as Measured by as Measured by Medical Record	Baseline, Up to 10 minutes
Change in Systolic Blood Pressure as Measured by Medical Record	Baseline, Up to 10 minutes
Change in CO2 Level as Measured by Medical Record	Baseline, Up to 10 minutes
Pain Score as Measured by the Behavior Pain Scale	Up to 10 minutes	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.
Change in Oxygen Saturation Level as Measured by Medical Record	Baseline, Up to 10 minutes

Secondary Outcome Measures

Name	Time	Method

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