Use of Local Warming in Children Venipuncture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by University of Florence.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Phobia Phlebotomy
Other: Emla + Local Warming
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 72
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543009

Contacts
Contact: Filippo Festini, MSN +39 347 2108993 filippo.festini@unifi.it

Locations
Italy
Meyer Children Hospital Recruiting
Florence, Italy, 50139
Contact: Filippo Festini, RN, BA, BSN, MSN    39 3472108993    filippo.festini@unifi.it   
Principal Investigator: Sofia Bisogni, RN, BSN, MSN         
Sponsors and Collaborators
University of Florence
Investigators
Principal Investigator: Filippo Festini, RN, BA, BSN, MSN University of Florence
  More Information

No publications provided

Responsible Party: Filippo Festini, Professor of Nursing, University of Florence
ClinicalTrials.gov Identifier: NCT01543009     History of Changes
Other Study ID Numbers: UFI2012WARM
Study First Received: February 27, 2012
Last Updated: September 12, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Florence:
child
venipuncture
pain

Additional relevant MeSH terms:
EMLA
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Combined

ClinicalTrials.gov processed this record on October 01, 2014