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

The Effect of a Sugar-free-flavored-sweet-tasting-solution on Pain Associated With Dental Injections in Pediatric Patients

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 Overview

• Status: Completed
• Conditions: Pain; Pediatric Patients; Injection Pain; Injection Pain Prevention; Local Anesthesia Infiltration
• Intervention / Treatment: Other: Sugar-free-flavored sweet tasting solution; Other: Placebo (sterile-water)

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan
    • Lamis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Other: Placebo (sterile-water); Placebo (sterile water)
Active Comparator: Sugar-free-flavored sweet tasting solution Group	Other: Sugar-free-flavored sweet tasting solution; A sugar-free-flavored sweet tasting solution that is anticipated to reduce the pain of local anaesthesia injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	Baseline and During Injection

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: clinical trial; dental anxiety; dental pain; injection pain; split-mouth; dental fear; SFSS; sugar-free solution; local anesthesia pain; children dental pain; sugar-free flavored sweet tasting solution; dental fear reduction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Toothache
• Other Study ID Numbers: UJordanLamis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No