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Clinical trial

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

ID
Name
Buzzy System in Children.
Description
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.
Trial arms
Trial start
2022-07-23
Estimated PCD
2022-12-22
Trial end
2023-05-06
Status
Completed
Treatment
Buzzy System
Vibrating Device
Arms:
Buzzy System
Topical anesthetic
20% benzocaine gel (Opahl Topical Gel)
Arms:
Control
1.8 ml of 4% articaine hydrochloride with epinephrine 1:100,000
Local dental anesthetic agent
Arms:
Buzzy System, Control
Size
70
Primary endpoint
Pain Perception during local anaesthesia injection
Procedure (During and immediately after the administration of local anesthesia)
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Both the patient and the investigator cannot be blinded due to the different techniques.', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}
Updated at
2024-03-21

1 organization

2 products

1 indication

Organization
Cairo University
Product
Topical anesthetic
Indication
Local Anaesthesia
Product
Articaine hydrochloride with Epinephrine