The Effect of a Sugar-free-flavored-sweet-tasting-solution on Pain Associated With Dental Injections in Pediatric Patients
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Jordan
- Enrollment
- 54
- Primary Endpoint
- Self-reported pain using faces pain scale-revised (FPS-r)
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Outcomes
Primary Outcomes
Self-reported pain using faces pain scale-revised (FPS-r)
Time Frame: Immediately after local anesthetic injection
Pain intensity measured using the Faces Pain Scale - Revised (FPS-R), ranging from 0 to 10, where higher scores indicate greater pain.
Observer-reported pain using Revised Face, Legs, Activity, Cry, Consolability Scale
Time Frame: During administration of the local anesthetic injection
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.
Physiological-Heart Rate
Time Frame: Baseline and During Injection
Changes in heart rate measured in beats per minute (bpm); increases in heart rate indicate higher physiological arousal associated with pain
Secondary Outcomes
No secondary outcomes reported
Investigators
Lamis D. Rajab
Prof
University of Jordan