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

N/ANot Yet RecruitingNCT07279285

University of Jordan54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Injection Pain Local Anesthesia Infiltration Pain Injection Pain Prevention Pediatric Patients

Interventions

Sugar-free-flavored sweet tasting solutionOTHER

A sugar-free-flavored sweet tasting solution that is anticipated to reduce the pain of local anaesthesia injections

Placebo (sterile-water)OTHER

Placebo (sterile water)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Self-reported pain using faces pain scale-revised (FPS-r)

Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.

Time frame: Immediately after local anesthetic injection

Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale

Pain behavior measured using the Face, Legs, Activity, Cry, Consolability - Revised (FLACC-R) Scale, scored from 0 to 10, where higher scores indicate greater pain-related distress.

Time frame: During administration of the local anesthetic injection

Physiological-Heart Rate

Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain

Time frame: Baseline and During Injection