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Use of Local Warming in Children Venipuncture

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

Status
Suspended
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01543009
Enrollment
72
Registered
2012-03-02
Start date
2012-03-31
Completion date
2016-10-31
Last updated
2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phobia Phlebotomy

Keywords

child, venipuncture, pain

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.

Interventions

OTHEREmla + 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

Sponsors

University of Florence
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
rate of success of peripheral venous cannulation at the first attemptThe outcome is observed and recorded immediatly after the venous cannulation. No follow up is required

Secondary

MeasureTime frameDescription
pain perceived by the child undergone to the cannulationThe outcome is observed and recorded immediatly after the venous cannulation. No follow up is requiredThe pain level is estimated using a visual analog scale (from 0 to 10) or the Wong faces' Scale
Difficulty in performing cannulation perceived by NurseThe outcome is observed and recorded immediatly after the venous cannulation. No follow up is requiredThis outcome is calculated using an ad hoc Visual Analog Scale (from 0 to 10)
Time needed to obtain cannulationFrom positioning tourniquet to completion of cannulation. No follow up is requiredTime is calculated in seconds

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026