Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
Recruiting now · Not applicable
Conditions studied: Pain Perception
In brief
Local anesthesia is an anxiety-provoking procedure. Pain control is important for effective behavior guidance, specially among pediatric patients. This study aims to evaluate the effectiveness of Buzzy® as a topical anesthetic in pain perception through two ways: once using vibration mode without the cold pack and the other using the cold pack without vibration and comparing it to topical anesthetic gel during different anesthetic techniques Methods: A randomized controlled clinical trial involving 72 healthy cooperative patients aged 5-9 years. They will be allocated to receive local anesthesia either using the vibration mode of Buzzy Bee (test group) or the cold pack of Buzzy Bee (test group) or conventional topical anesthetic gel (control group). Pain response will be assessed using Visual Analog Scale (VAS) and SEM scale.
Key facts
- Study ID
- NCT06841601
- Run by
- Alexandria University
- People needed
- 72
- Starts
- 2025-02-23
- Expected to finish
- 2025-03-25
- Last updated by the study team
- 2025-02-24
Who can join
Age: 5 and older, up to 9. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients indicated for simple restorative procedures.
- Children with physical status ASA I, II.
- Children with no learning disabilities
- Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
- Patients whom parents will give consent to participate
You may not qualify if…
- Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
- Patients with acute oral or facial infection (swelling and/or cellulites)
- Having active sites of pathosis in the area of injection that could affect anesthetic assessment.
- Children with special health care needs.
Where it is running
- Faculty of Dentistry- Alexandria University — Alexandria, Egypt (enrolling)
Full record on ClinicalTrials.gov
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