Buffered Local Anesthetic

Dental Pain Clinical Trial

Official title:

Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757648
• Other study ID #: STUDY20191693
• Status: Completed
• Phase: Phase 4
• Start date: December 8, 2020
• Est. completion date: June 12, 2023

Study information

• Verified date: August 2023
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

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

Related Conditions & MeSH terms

• Dental Pain
• Toothache

Intervention

Drug:
• Non-buffered Anesthetic
non-buffered LA, 2% lidocaine with epinephrine 1:100,000
• Buffered Anesthetic
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.

Device:
• Onset
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.

Locations

Country	Name	City	State
United States	Dental Clinic of Rainbow Center for Women and Children	Cleveland	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ying An, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10 minutes
Primary	Change in heart rate as measured by as measured by medical record		Baseline, Up to 10 minutes
Primary	Change in blood pressure as measured by medical record		Baseline, Up to 10 minutes
Primary	Change in CO2 level as measured by medical record		Baseline, Up to 10 minutes