NCT04695054

Buzzy Plus EMLA Cream for Vascular Access in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vascular Access

Interventions

Type	Name	Description
DEVICE	Buzzy device plus EMLA cream	EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure
DRUG	Only EMLA cream	EMLA cream will be applied 60 minutes before the needle procedure

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-01-05
• Last updated: 2024-06-13

Locations

1 site across 1 country: Italy