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Buzzy System Compared to Topical Anaesthesia During Infiltration Injection in Children.

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05083975
Collaborator
(none)
30
Enrollment
2
Arms
4.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Aim of the study is to test the effect of Buzzy System (vibrating device) compared to topical anaesthesia on pain reduction during injection of infiltration anaesthesia in children.

Condition or Disease Intervention/Treatment Phase
  • Device: Buzzy System
  • Drug: Topical anesthetic
  • Drug: Mepecaine - L 1.8 ml carpule
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Both the patient and the investigator cannot be blinded due to the different techniques.
Primary Purpose:
Treatment
Official Title:
Effect of Buzzy System (Vibrating Device) Compared to Topical Anaesthesia on Pain Reduction During Injection of Infiltration Anaesthesia in Children: A Randomized Clinical Trial Study.
Anticipated Study Start Date :
Jul 23, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Buzzy System

Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after activating the buzzy device extra orally proximal to the site of injection for 30-60 seconds.

Device: Buzzy System
Vibrating Device

Drug: Mepecaine - L 1.8 ml carpule
Local dental anesthetic agent
Active Comparator: Control

Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after application of 20% Benzocaine topical anesthestic gel.

Drug: Topical anesthetic
20% benzocaine gel (Opahl Topical Gel)

Drug: Mepecaine - L 1.8 ml carpule
Local dental anesthetic agent

Outcome Measures

Primary Outcome Measures

  1. Pain Perception during local anaesthesia injection [Procedure (During and immediately after the administration of local anesthesia)]

    Pain intensity directly after the injection recorded by Wong-Baker faces pain rating scale and Faces, Legs, Arms, Crying, Consolability (FLACC) scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Children classified as cooperative or potentially cooperative according to Wright's classification of child behaviour with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale.

  2. Children aged 5-8 years old.

  3. Patients who need maxillary buccal infiltration anesthesia.

Exclusion Criteria:

  1. Children with any neurological or psychological disorders.

  2. Children with known allergy to topical or local anesthetic agents.

  3. Parental refusal for participation.

  4. Children with previous history of local anesthesia injection.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fatma Mahmoud Mohamed Mahmoud, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05083975
Other Study ID Numbers:
  • Buzzy System in Children.
First Posted:
Oct 19, 2021
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local

Study Results

No Results Posted as of Jun 27, 2022