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

Cairo University (CU)

Status: Unknown

Conditions: Anesthesia, Local; Vibration; Anesthesia

Treatments: Device: buzzy device; Other: Conventinal anasthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05067218

Buzzy device in Children.

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

buzzy device (intervention)

Active Comparator group

Description:

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.

Treatment:

Device: buzzy device

Conventinal anasthesia ( control )

Experimental group

Description:

* 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.

Treatment:

Other: Conventinal anasthesia