Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children

Last updated: February 20, 2025
Sponsor: Alexandria University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

topical anesthetic gel

Cold pack

Vibration

Clinical Study ID

NCT06841601
0568-12/22
  • Ages 5-9
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients indicated for simple restorative procedures.

  2. Children with physical status ASA I, II.

  3. Children with no learning disabilities

  4. Positive or definitely positive behavior during preoperative assessments accordingto the Frankl Scale.

  5. Patients whom parents will give consent to participate

Exclusion

Exclusion Criteria:

  1. Patients allergic to local anesthesia or having a family history of allergy to localanesthesia.

  2. Patients with acute oral or facial infection (swelling and/or cellulites)

  3. Having active sites of pathosis in the area of injection that could affectanesthetic assessment.

  4. Children with special health care needs.

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: topical anesthetic gel
Phase:
Study Start date:
February 23, 2025
Estimated Completion Date:
March 25, 2025

Connect with a study center

  • Faculty of Dentistry- Alexandria University

    Alexandria, 21511
    Egypt

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.