Effect of Buzzy System (Vibrating Device) Compared to Topical Anaesthesia on Pain Reduction During Injection of Infiltration Anaesthesia in Children: A Randomized Clinical Trial.
Overview
- Phase
- N/A
- Intervention
- Buzzy System
- Conditions
- Local Anaesthesia
- Sponsor
- Cairo University
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Pain Perception during local anaesthesia injection
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Fatma Mahmoud Mohamed Mahmoud
Principal Investigator
Cairo University
Eligibility Criteria
Inclusion Criteria
- •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.
- •Children aged 5-8 years old.
- •Patients who need maxillary buccal infiltration anesthesia.
Exclusion Criteria
- •Children with any neurological or psychological disorders.
- •Children with known allergy to topical or local anesthetic agents.
- •Parental refusal for participation.
- •Children with previous history of local anesthesia injection.
Arms & Interventions
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.
Intervention: Buzzy System
Control
Maxillary anesthetic infiltration injection using a conventional 2-ml syringe and a short needle after application of 20% Benzocaine topical anesthestic gel.
Intervention: Topical anesthetic
Outcomes
Primary Outcomes
Pain Perception during local anaesthesia injection
Time Frame: 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.