Use of Local Warming in Children Venipuncture

NCT01543009 | Suspended Early Phase 1 DMC

• 1 other identifier: UFI2012WARM
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Phobia Phlebotomy

Keywords

child; venipuncture; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Difficulty in performing cannulation perceived by Nurse

  The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required

• Time needed to obtain cannulation

  From positioning tourniquet to completion of cannulation. No follow up is required

Study Arms (2)

Emla + no additional intervention

NO INTERVENTION

Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming

Emla + Local Warming

EXPERIMENTAL

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

Interventions

Emla + Local Warming OTHER

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

Emla + Local Warming

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Meyer Children Hospital

Florence, 50139, Italy

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine, Prilocaine Drug Combination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Filippo Festini, RN, BA, BSN, MSN

  University of Florence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 2, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

IT (1)