Use of Local Warming in Children Venipuncture

Early Phase 1

Suspended

• Conditions: Phobia Phlebotomy
• Interventions: Other: Emla + Local Warming

• Registration Number: NCT01543009
• Lead Sponsor: University of Florence

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 available

Study Timeline

• Study First Submitted: 2012-02-27
• Study Start: 2012-03
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-02
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emla + Local Warming	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Time needed to obtain cannulation	From positioning tourniquet to completion of cannulation. No follow up is required	Time is calculated in seconds
pain perceived by the child undergone to the cannulation	The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required	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	The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required	This outcome is calculated using an "ad hoc" Visual Analog Scale (from 0 to 10)

Trial Locations

Locations (1)

Meyer Children Hospital; 🇮🇹 Florence, Italy