Injection Pain, Injection Pain Prevention, Local Anesthesia Infiltration, Pain, Pediatric Patients
Conditions
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
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
Interventions
OTHERSugar-free-flavored sweet tasting solution
A sugar-free-flavored sweet tasting solution that is anticipated to reduce the pain of local anaesthesia injections
OTHERPlacebo (sterile-water)
Placebo (sterile water)
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported pain using faces pain scale-revised (FPS-r) | 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 | 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 | 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 |
Countries
Jordan
Outcome results
None listed