Use of Local Warming in Children Venipuncture

This study is currently recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2012

Last Updated Date

September 12, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

rate of success of peripheral venous cannulation at the first attempt [ Time Frame: After each attempt ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01543009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Local Warming in Children Venipuncture

Official Title ^ICMJE

Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Phobia Phlebotomy

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 13 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Filippo Festini, MSN

+39 347 2108993

filippo.festini@unifi.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01543009

Other Study ID Numbers ^ICMJE

UFI2012WARM

Has Data Monitoring Committee

Yes

Responsible Party

Filippo Festini, University of Florence

Study Sponsor ^ICMJE

University of Florence

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Filippo Festini, RN, BA, BSN, MSN

University of Florence

Information Provided By

University of Florence

Verification Date

September 2012

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

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