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

Cairo University (CU)

Status: Completed

Conditions: Local Anaesthesia

Treatments: Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000; Drug: Topical anesthetic; Device: Buzzy System

Study type: Interventional

Funder types: Other

Identifiers

NCT05083975

Buzzy System in Children.

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Buzzy System

Experimental group

Description:

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.

Treatment:

Device: Buzzy System

Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000

Control

Active Comparator group

Description:

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

Treatment:

Drug: 1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000

Drug: Topical anesthetic