Vascular Access
Conditions
Keywords
Children, Buzzy device, EMLA cream, Peripheral vascular access
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.
Interventions
DEVICEBuzzy device plus EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure
DRUGOnly EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure
Sponsors
IRCCS Burlo Garofolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
Countries
Italy
Outcome results
None listed