Sweet-Tasting Solution Versus Placebo to Reduce Pain During Local Anesthetic Injection in Children (NCT07279285) | Clinical Trial Compass
CompletedNot Applicable
Sweet-Tasting Solution Versus Placebo to Reduce Pain During Local Anesthetic Injection in Children
Jordan54 participantsStarted 2026-01-01
Plain-language 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
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is already completed, is there any published data or results available that my child's doctor could review to decide whether giving a sweet-tasting solution before a local anesthetic injection might help reduce my child's pain during procedures?
2This study measured pain using children's self-reported faces and observer-rated behavioral scales — how reliable are those tools for my child's age, and would my child's doctor use a similar approach to assess pain during their own injections?
3The trial compared a sweet solution against a placebo rather than against an established pain-reduction technique — are there other already-proven methods, like numbing cream or distraction techniques, that my child's doctor would recommend alongside or instead of this approach?
4Since this was a Phase NA (non-drug intervention) study focused on a simple, low-risk addition like a sweet solution, does my child's doctor think the potential benefit is strong enough to try during our next procedure, even before full results are widely published?
5The trial tracked heart rate as a physiological measure of pain response — would my child's doctor monitor something similar during their local anesthetic procedure to get a more objective picture of how much discomfort my child is actually experiencing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Self-reported pain using faces pain scale-revised (FPS-r)
Timeframe: Immediately after local anesthetic injection
2
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
Timeframe: During administration of the local anesthetic injection