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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buzzy and EMLA Cream | Experimental | 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 | Active Comparator | In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy device plus EMLA cream | Device | EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Strajn, Nurse | Institute for Maternal and Child Health IRCCS Burlo Garofolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS materno infantile Burlo Garofolo | Trieste | TS | 34100 | Italy |
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| Only EMLA cream | Drug | EMLA cream will be applied 60 minutes before the needle procedure |
|
| 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 |