Use of Local Warming in Children Venipuncture

Phobia Phlebotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01543009
• Other study ID #: UFI2012WARM
• Status: Suspended
• Phase: Phase 0
• First received: February 27, 2012
• Last updated: October 28, 2015
• Start date: March 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2015
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 72
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Phobia Phlebotomy

Intervention

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

Locations

Country	Name	City	State
Italy	Meyer Children Hospital	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of success of peripheral venous cannulation at the first attempt		The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required	No
Secondary	pain perceived by the child undergone to the cannulation	The pain level is estimated using a visual analog scale (from 0 to 10) or the Wong "faces'" Scale	The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required	No
Secondary	Difficulty in performing cannulation perceived by Nurse	This outcome is calculated using an "ad hoc" Visual Analog Scale (from 0 to 10)	The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required	No
Secondary	Time needed to obtain cannulation	Time is calculated in seconds	From positioning tourniquet to completion of cannulation. No follow up is required	No