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

October 3, 2021 updated by: Mai Gamal Eldeen Hassan Sabra, Cairo University
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
bee shaped with wings could be frozen.
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
normal technique of injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain perception during LA injection
Time Frame: one hour
by wong baker scale
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate during injection of local anesthesia.
Time Frame: one hour
pulse oximeter
one hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's behavior during local anesthesia injection.
Time Frame: one hour
FLACC scale
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2021

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

November 15, 2022

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

October 3, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Buzzy device in Children.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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