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

Effect of Buzzy System (Vibrating Device) Compared to Topical Anaesthesia on Pain Reduction During Injection of Infiltration Anaesthesia in Children: A Randomized Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05083975
Enrollment
70
Registered
2021-10-19
Start date
2022-07-23
Completion date
2023-05-06
Last updated
2024-03-21

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

Conditions

Local Anaesthesia

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.

Interventions

DEVICEBuzzy System

Vibrating Device

20% benzocaine gel (Opahl Topical Gel)

DRUG1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000

Local dental anesthetic agent

Sponsors

Cairo University
Lead SponsorOTHER

Study design

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

Masking description

Both the patient and the investigator cannot be blinded due to the different techniques.

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Perception during local anaesthesia injectionProcedure (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.

Countries

Egypt

Outcome results

None listed

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