Actively Recruiting
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
Led by Alexandria University · Updated on 2025-02-24
72
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 to 9 years indicated for simple restorative procedures
- Physical status ASA I or II
- No learning disabilities
- Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale
- Parental consent to participate
You will not qualify if you...
- Allergy to local anesthesia or family history of such allergy
- Acute oral or facial infection such as swelling or cellulitis
- Active sites of pathosis in the injection area affecting anesthetic assessment
- Children with special health care needs
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Dentistry- Alexandria University
Alexandria, Egypt, 21511
Actively Recruiting
Research Team
D
Dina A Sharaf, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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