Buzzy Plus EMLA Cream for Vascular Access in Children
Status:
Not yet recruiting
Trial end date:
2022-01-15
Target enrollment:
Participant gender:
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.