Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
94 participants
INTERVENTIONAL
2023-04-01
2023-12-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Buzzy and 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.
Buzzy device plus EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure
EMLA Cream
In the control group children will receive the application of EMLA cream 60 minutes before the needle procedure
Only EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure
Interventions
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Buzzy device plus EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure
Only EMLA cream
EMLA cream will be applied 60 minutes before the needle procedure
Eligibility Criteria
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Inclusion Criteria
* children who have applied EMLA cream at least 60 minutes before the procedure
Exclusion Criteria
* 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
4 Years
12 Years
ALL
No
Sponsors
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IRCCS Burlo Garofolo
OTHER
Responsible Party
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Principal Investigators
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Tamara Strajn, Nurse
Role: PRINCIPAL_INVESTIGATOR
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Locations
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IRCCS materno infantile Burlo Garofolo
Trieste, TS, Italy
Countries
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Other Identifiers
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RC 12/2019
Identifier Type: -
Identifier Source: org_study_id
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