CClinicalTrials.gg
Status unknownNCT05067218Updated Oct 5, 2021

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

An interventional study of buzzy device and Conventinal anasthesia in Anesthesia, Anesthesia, Local and Vibration, sponsored by Cairo University. Status unknown. Open to participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-05.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
6 Years to 11 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Anesthesia
  • Anesthesia, Local
  • Vibration
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 11 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Children with a behavioral management problem.
  • Children with known allergy to local anesthetic agents.
  • Parental refusal for participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
12 participants (estimated)

Study arms

  • Active comparator
    buzzy device (intervention)

    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.

    Device: buzzy device

  • Experimental
    Conventinal anasthesia ( control )

    * 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.

    Other: Conventinal anasthesia

Interventions

  • Devicebuzzy device

    bee shaped with wings could be frozen.

  • OtherConventinal anasthesia

    normal technique of injection

06

What researchers measure

Primary outcomes

  1. Pain perception during LA injection

    by wong baker scale

    Time frame: one hour

Secondary outcomes

  1. Heart rate during injection of local anesthesia.

    pulse oximeter

    Time frame: one hour

Other outcomes

  1. Child's behavior during local anesthesia injection.

    FLACC scale

    Time frame: one hour

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05067218
Lead sponsor
Cairo University
Responsible party
Mai Gamal Eldeen Hassan Sabra (principal investigator, Cairo University) — Principal investigator
First posted
Oct 5, 2021
Start date
Oct 15, 2021 (estimated)
Primary completion
Oct 15, 2022 (estimated)
Completion
Nov 15, 2022 (estimated)
Last update
Oct 5, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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