Combined Use of Buzzy and EMLA Cream for Vascular Access in Children. A Randomized Controlled Trial

RC 12/2019

Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children. The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure. The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.

2023-04-01

2023-12-01

2023-12-01

Completed

94

Inclusion Criteria: * children between 4 and 12yrs of age needing venipuncture or peripheral vascular access * children who have applied EMLA cream at least 60 minutes before the procedure Exclusion Criteria: * children with cognitive impairment * children with skin lesion that does not allow the application of Buzzy device * children diseases that cause hypersensibility to cold (i.e. Raynaud syndrome, sickle cell disease) * children who have taken any analgesics in the 8 hours before enrollment

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 94, 'type': 'ACTUAL'}}

2024-03-19