Use of Local Warming in Children Venipuncture

Study Overview
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Brief Summary
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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.

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

Conditions
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Phobia Phlebotomy

Intervention / Treatment
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* Other: Emla + Local Warming


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Emla + no additional intervention<br>Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming | |
| Experimental: Emla + Local Warming<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Time needed to obtain cannulation | Time is calculated in seconds | From positioning tourniquet to completion of cannulation. No follow up is required | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, venipuncture, pain