Sweet-Tasting Solution Versus Placebo to Reduce Pain During Local Anesthetic Injection in Children

University of Jordan

Status: Not yet enrolling

Conditions: Local Anesthesia Infiltration; Injection Pain; Pediatric Patients; Pain; Injection Pain Prevention

Treatments: Other: Placebo (sterile-water); Other: Sugar-free-flavored sweet tasting solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07279285

UJordanLamis

Details and patient eligibility

About

The goal of this clinical trial is to learn whether applying a sugar-free flavored sweet solution (SFSS) before local anesthesia helps reduce injection pain in children.

The main question it aims to answer is:

Does SFSS reduce pain during dental local anesthesia compared to a placebo (plain water)? Researchers will compare the use of SFSS and a placebo to see which results in lower pain scores.

Participants will:

Receive SFSS or placebo before local anesthesia during two dental visits Have their pain measured using self-reported and observational pain scales Have their heart rate monitored during the procedure

Enrollment: 54 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Children who are 6-12 years of age.
2. Children classified as ASA1 according to the American Society of Anesthesiologists.
3. Children who have positive (Class III) or definitely positive (Class IV) behavior during preoperative behavioral assessments according to the Frankl Scale.
4. Children who required bilateral local anesthesia infiltration injections on primary or permanent teeth either in the maxilla or mandible for dental treatment (different types of restoration, stainless steel crowns, pulp therapy, and extractions).
5. Children with positive consent forms (signed and approved by their parents/ legal guardians) and attended the appointment.

Exclusion criteria

1. Children who had a history of unpleasant experiences in dental settings.
2. Children who had a history of unpleasant experience with local anesthesia injection.
3. The presence of medically or developmentally compromising conditions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Sugar-free-flavored sweet tasting solution Group

Active Comparator group

Treatment:

Other: Sugar-free-flavored sweet tasting solution

Placebo Group

Placebo Comparator group

Treatment:

Other: Placebo (sterile-water)