Buzzy Plus EMLA Cream for Vascular Access in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Vascular Access

Intervention / Treatment
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* Device: Buzzy device plus EMLA cream
* Drug: Only EMLA cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buzzy and EMLA Cream<br>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. | Device: Buzzy device plus EMLA cream<br>* EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure<br>|
| Active Comparator: EMLA Cream<br>In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure | Drug: Only EMLA cream<br>* EMLA cream will be applied 60 minutes before the needle procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean distress evaluated by parents | 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) | Intraprocedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean distress evaluated by operators | 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) | intraprocedural | 
| Mean pain score evaluated by children | 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). | Immediately after the procedure | 
| Mean pain score evaluated by parents | 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). | Immediately after the procedure | 
| Mean pain score evaluated by operators | 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). | Immediately after the procedure | 
| Success at first attempt | Percentage of success of the procedure on the first attempt in the two groups | Intraprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Buzzy device, EMLA cream, Peripheral vascular access