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Recruiting
NCT05757648
Buffered Local Anesthetic
Conditions: Dental Pain
Sex: All
Ages: 2 Years – 6 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 20
Sponsor: Ying An, MD
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Healthy children or children with mild controlled systemic illnessTreatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administrationExclusion 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 diseasesAntibiotic premedication requirementHistory of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessmentHas signs of dental pain, odontogenic abscess or facial cellulitisAllergy to local anesthetics or sulfites
Source: ClinicalTrials.gov (NCT05757648). StuddyBuddy aggregates publicly available trial information.