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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05067218
• Other study ID #: Buzzy device in Children.
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: November 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia, Local
• Vibration

Intervention

Device:
• buzzy device
bee shaped with wings could be frozen.

Other:
• Conventinal anasthesia
normal technique of injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child's behavior during local anesthesia injection.	FLACC scale	one hour
Primary	Pain perception during LA injection	by wong baker scale	one hour
Secondary	Heart rate during injection of local anesthesia.	pulse oximeter	one hour