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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SUSPENDED
EARLY_PHASE1
72 participants
INTERVENTIONAL
2012-03-31
2016-10-31
Brief Summary
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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
SINGLE
Study Groups
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Emla + no additional intervention
Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming
No interventions assigned to this group
Emla + Local Warming
Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) plus warming with a heating pad at 40°C for 5 minutes
Emla + Local Warming
In this arm Emla is applied 60 minutes before the procedure and then the site of venepuncture is warmed by an electric heating sand pad at the temperature of 40°C for 5 minutes before performing cannulation
Interventions
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Emla + Local Warming
In this arm Emla is applied 60 minutes before the procedure and then the site of venepuncture is warmed by an electric heating sand pad at the temperature of 40°C for 5 minutes before performing cannulation
Eligibility Criteria
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Inclusion Criteria
* Intravenous drug therapy prescribed by a physician
* no allergy to lidocaine
* no local skin disease
* absence of burns scars
* child and his/her family are native speaker of Italian
* BMI not lower than 10° centile for sex and age according to the CDC standards
Exclusion Criteria
* Intravenous drug therapy not needed
* Presence of an allergy to lidocaine products
* Skin disease
* Presence of burns scars
* The child or his/her family are not native speaker Italian
* BMI lower than 10° centile according to the CDC standards
8 Years
13 Years
ALL
No
Sponsors
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University of Florence
OTHER
Responsible Party
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Filippo Festini
Professor of Nursing
Principal Investigators
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Filippo Festini, RN, BA, BSN, MSN
Role: PRINCIPAL_INVESTIGATOR
University of Florence
Locations
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Meyer Children Hospital
Florence, , Italy
Countries
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Other Identifiers
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UFI2012WARM
Identifier Type: -
Identifier Source: org_study_id
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