Buffered Local Anesthetic

University Hospitals (UH)

Status and phase: Completed; Phase 4

Conditions: Dental Pain

Treatments: Drug: Non-buffered Anesthetic; Device: Onset; Drug: Buffered Anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT05757648

STUDY20191693

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Buffered Anesthetic Side/Non-buffered Anesthetic Side

Experimental group

Description:

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.

Treatment:

Drug: Buffered Anesthetic

Device: Onset

Drug: Non-buffered Anesthetic