Effectiveness of Vibratory Versus Cold Stimuli on Pain Perception in Children

Not Applicable

Recruiting

• Conditions: Pain Perception

• Registration Number: NCT06841601
• Lead Sponsor: Alexandria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study Start: 2025-02-23
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 according to the Frankl Scale.
5. Patients whom parents will give consent to participate

Exclusion Criteria

1. Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
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 affect anesthetic assessment.
4. Children with special health care needs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain perception during needle insertion in different anesthetic techniques Using SEM scale	during the procedure (needle insertion)	Objective method of pain assessment using SEM (sound, eye and movement scale). It is a behavioral assessment tool to evaluate pain and distress responses in children during dental procedures. It uses scores from 0 till 3 according to increasing levels of distress.

Secondary Outcome Measures

Name	Time	Method
Pain will be assessed after local anesthesia injection by means of Visual analogue scale.	immediately after the procedure (needle insertion)	Subjective method of pain assessment where patients will be instructed how to point to the position on the line between faces to indicate how much pain they felt during local anesthesia administration. The total scores range from 0 to 10. Happy to sad faces are connected to the line, with a higher score indicating more severe pain

Trial Locations

Locations (1)

Faculty of Dentistry- Alexandria University; 🇪🇬 Alexandria, Egypt