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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar-free-flavored sweet tasting solution Group | Active Comparator |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lamis | Amman | Jordan |
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| Placebo (sterile-water) | Other | Placebo (sterile water) |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| D014098 | Toothache |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
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