Actively Recruiting

Phase Not Applicable
Age: 5Years - 9Years
All Genders
NCT06841601

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

Age: 5Years - 9Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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