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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04695054
Study type Interventional
Source IRCCS Burlo Garofolo
Contact
Status Completed
Phase N/A
Start date April 1, 2023
Completion date December 1, 2023

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