Buzzy Plus EMLA Cream for Vascular Access in Children

Not Applicable

Completed

• Conditions: Vascular Access
• Interventions: Device: Buzzy device plus EMLA cream; Drug: Only EMLA cream

• Registration Number: NCT04695054
• Lead Sponsor: IRCCS Burlo Garofolo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-05
• Study Start: 2023-04-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buzzy and EMLA Cream	Buzzy device plus EMLA cream	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.
EMLA Cream	Only EMLA cream	In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure

Primary Outcome Measures

Name	Time	Method
Mean distress evaluated by parents	Intraprocedural	Distress score will be recorded by parents through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)

Secondary Outcome Measures

Name	Time	Method
Mean pain score evaluated by parents	Immediately after the procedure	Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). It includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Mean pain score evaluated by operators	Immediately after the procedure	Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). It includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).
Success at first attempt	Intraprocedural	Percentage of success of the procedure on the first attempt in the two groups
Mean distress evaluated by operators	intraprocedural	Distress score will be recorded through the use of the Children's Emotional Manifestation Scale (CEMS scale). The CEMS scale is an observational scale validated for recording procedural distress in children. It takes into consideration the following characteristics: facial expression, vocalization, activity, interaction, cooperation, with a score ranging from a minimum of 5 (no distress) to a maximum of 25 (serious distress)
Mean pain score evaluated by children	Immediately after the procedure	Pain scores will be reported through the Faces Pain Scale Revised (FPS-R scale). The FPS-R algometric scale is appropriate for the detection of pain in children aged 4 to 12 years, as it includes both a series of smiley faces with an expression that changes according to increasing pain, and a numerical scale, for a pain scale ranging from zero (no pain) to 10 (severe pain).

Trial Locations

Locations (1)

IRCCS materno infantile Burlo Garofolo; 🇮🇹 Trieste, TS, Italy