Use of Local Warming in Children Venipuncture

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Florence
Sponsor:
Information provided by (Responsible Party):
Filippo Festini, University of Florence
ClinicalTrials.gov Identifier:
NCT01543009
First received: February 27, 2012
Last updated: September 12, 2012
Last verified: September 2012

February 27, 2012
September 12, 2012
March 2012
November 2012   (final data collection date for primary outcome measure)
rate of success of peripheral venous cannulation at the first attempt [ Time Frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required ] [ Designated as safety issue: No ]
rate of success of peripheral venous cannulation at the first attempt [ Time Frame: After each attempt ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01543009 on ClinicalTrials.gov Archive Site
  • pain perceived by the child undergone to the cannulation [ Time Frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required ] [ Designated as safety issue: No ]
    The pain level is estimated using a visual analog scale (from 0 to 10) or the Wong "faces'" Scale
  • Difficulty in performing cannulation perceived by Nurse [ Time Frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required ] [ Designated as safety issue: No ]
    This outcome is calculated using an "ad hoc" Visual Analog Scale (from 0 to 10)
  • Time needed to obtain cannulation [ Time Frame: From positioning tourniquet to completion of cannulation. No follow up is required ] [ Designated as safety issue: No ]
    Time is calculated in seconds
  • pain perceived by the child undergone to the cannulation [ Time Frame: at completion of cannulation ] [ Designated as safety issue: No ]
    The pain level is estimated using a visual analog scale (from 0 to 10) or the Wong "faces'" Scale
  • Difficulty in performig cannulation perceived by Nurse [ Time Frame: at completion of cannulation ] [ Designated as safety issue: No ]
    This outcome is calculated using an "ad hoc" Visual Analog Scale (from 0 to 10)
  • Time needed to obtain cannulation [ Time Frame: From positioning tourniquet to completion of cannulation ] [ Designated as safety issue: No ]
    Time is calculated in seconds
Not Provided
Not Provided
 
Use of Local Warming in Children Venipuncture
Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial.

The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Phobia Phlebotomy
Other: 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
  • No Intervention: Emla + no additional intervention
    Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming
  • Experimental: 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
    Intervention: Other: Emla + Local Warming
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age between 8 and 13 years
  • 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:

  • age of child not included in the age range established for the study
  • 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
Both
8 Years to 13 Years
No
Contact: Filippo Festini, MSN +39 347 2108993 filippo.festini@unifi.it
Italy
 
NCT01543009
UFI2012WARM
Yes
Filippo Festini, University of Florence
University of Florence
Not Provided
Principal Investigator: Filippo Festini, RN, BA, BSN, MSN University of Florence
University of Florence
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP