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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05067218
Enrollment
12
Registered
2021-10-05
Start date
2021-10-15
Completion date
2022-11-15
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Anesthesia, Local, Vibration

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.

Interventions

bee shaped with wings could be frozen.

OTHERConventinal anasthesia

normal technique of injection

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blinding of the operator and the patients will not be applicable due to the difference between the used techniques, however, the statistician will be blinded.

Intervention model description

split mouth

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain perception during LA injectionone hourby wong baker scale

Secondary

MeasureTime frameDescription
Heart rate during injection of local anesthesia.one hourpulse oximeter

Other

MeasureTime frameDescription
Child's behavior during local anesthesia injection.one hourFLACC scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026