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

NCT07279285 | Completed DMC

• 1 other identifier: UJordanLamis
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

clinical trial; sugar-free solution; local anesthesia pain; dental pain; injection pain; children dental pain; split-mouth; sugar-free flavored sweet tasting solution; SFSS; dental fear reduction; dental fear; dental anxiety

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Sugar-free-flavored sweet tasting solution Group

ACTIVE COMPARATOR

Other: Sugar-free-flavored sweet tasting solution

Placebo Group

PLACEBO COMPARATOR

Other: Placebo (sterile-water)

Interventions

Sugar-free-flavored sweet tasting solution OTHER

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

Sugar-free-flavored sweet tasting solution Group

Placebo (sterile-water) OTHER

Placebo (sterile water)

Placebo Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children who are 6-12 years of age.
• Children classified as ASA1 according to the American Society of Anesthesiologists.
• Children who have positive (Class III) or definitely positive (Class IV) behavior during preoperative behavioral assessments according to the Frankl Scale.
• 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).
• Children with positive consent forms (signed and approved by their parents/ legal guardians) and attended the appointment.

You may not qualify if:

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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Lamis

Amman, Jordan

Location

MeSH Terms

Conditions

Pain; Toothache

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JO (1)