Effect of External Cold and Vibration (Buzzy Device) Versus the Conventional Technique on Pain Perception During Local Anesthesia Injection in Children.

Not Applicable

• Conditions: Anesthesia; Vibration; Anesthesia, Local
• Interventions: Device: buzzy device; Other: Conventinal anasthesia

• Registration Number: NCT05067218
• Lead Sponsor: Cairo University

Brief Summary

This study adopts the null hypothesis (There is no difference in pain perception during local anesthesia injection with the buzzy device in comparison to the conventional technique).

Detailed Description

The injection of local anesthesia in children is usually associated with fear, anxiety, and discomfort. There is an essential need to develop techniques that decrease pain during injection, preventing patients from avoiding dental treatment.The efficacy of a child-friendly device, having a combined effect of vibration and distraction, with the conventional method of injection on pain, anxiety, and behavior of pediatric patients. The evaluation the pain perception and comfort of the patient during local anesthesia delivery using the Buzzy device and conventional syringe and revealed that the external cold and vibration via Buzzy can reduce pain and anxiety during local anesthetic delivery for various dental procedures.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-03
• Last Update Submitted: 2021-10-03
• Study First Posted: 2021-10-05
• Last Update Posted: 2021-10-05
• Study Start: 2021-10-15
• Primary Completion: 2022-10-15
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour.
• Medically fit children (ASA I, II).
• Children mentally capable of communication.
• Children aged 6-11 years.
• First dental visit.
• Patient requiring inferior alveolar nerve block local anesthesia injection for dental treatment.

Exclusion Criteria

• Children with a behavioral management problem.
• Children with known allergy to local anesthetic agents.
• Parental refusal for participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
buzzy device (intervention)	buzzy device	The wings of buzzy device will be kept frozen and once the child is ready, the frozen wing will be attached to the device and Buzzy will be placed extra-orally above the area/cheek where local anesthetic is to be delivered.
Conventinal anasthesia ( control )	Conventinal anasthesia	* The site of injection will be dried then topical anesthetic gel of 20% benzocaine (Dharma Ophal-S) will be applied. The duration of application of gel will be 1 minute. * Local anesthetic solution will be delivered using a standard aspirating syringe with 27-gauge, 21 mm short needles.

Primary Outcome Measures

Name	Time	Method
Pain perception during LA injection	one hour	by wong baker scale

Secondary Outcome Measures

Name	Time	Method
Heart rate during injection of local anesthesia.	one hour	pulse oximeter