Buzzy Plus EMLA Cream for Vascular Access in Children

IRCCS Burlo Garofolo

Status: Completed

Conditions: Vascular Access

Treatments: Device: Buzzy device plus EMLA cream; Drug: Only EMLA cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04695054

RC 12/2019

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Buzzy and EMLA Cream

Experimental group

Description:

In the experimental group children will receive the application of EMLA cream 60 minutes before the needle procedure and the use of Buzzy device during the procedure.

Treatment:

Device: Buzzy device plus EMLA cream

EMLA Cream

Active Comparator group

Description:

In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure

Treatment:

Drug: Only EMLA cream