Use of Local Warming in Children Venipuncture
This study is currently recruiting participants.
Verified September 2012 by University of Florence
Sponsor:
University of Florence
Information provided by (Responsible Party):
Filippo Festini, University of Florence
ClinicalTrials.gov Identifier:
NCT01543009
First received: February 27, 2012
Last updated: September 12, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Phobia Phlebotomy |
Other: Emla + Local Warming |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by University of Florence:
Primary Outcome Measures:
- rate of success of peripheral venous cannulation at the first attempt [ Time Frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- pain perceived by the child undergone to the cannulation [ Time Frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required ] [ Designated as safety issue: No ]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 [ Time Frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required ] [ Designated as safety issue: No ]This outcome is calculated using an "ad hoc" Visual Analog Scale (from 0 to 10)
- Time needed to obtain cannulation [ Time Frame: From positioning tourniquet to completion of cannulation. No follow up is required ] [ Designated as safety issue: No ]Time is calculated in seconds
| Estimated Enrollment: | 72 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Emla + no additional intervention
Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming
|
|
|
Experimental: 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
|
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
|
Eligibility| Ages Eligible for Study: | 8 Years to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543009
Contacts
| Contact: Filippo Festini, MSN | +39 347 2108993 | filippo.festini@unifi.it |
Locations
| Italy | |
| Meyer Children Hospital | Recruiting |
| Florence, Italy, 50139 | |
| Contact: Filippo Festini, RN, BA, BSN, MSN 39 3472108993 filippo.festini@unifi.it | |
| Principal Investigator: Sofia Bisogni, RN, BSN, MSN | |
Sponsors and Collaborators
University of Florence
Investigators
| Principal Investigator: | Filippo Festini, RN, BA, BSN, MSN | University of Florence |
More Information
No publications provided
| Responsible Party: | Filippo Festini, Professor of Nursing, University of Florence |
| ClinicalTrials.gov Identifier: | NCT01543009 History of Changes |
| Other Study ID Numbers: | UFI2012WARM |
| Study First Received: | February 27, 2012 |
| Last Updated: | September 12, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Florence:
|
child venipuncture pain |
Additional relevant MeSH terms:
|
Phobic Disorders Anxiety Disorders Mental Disorders EMLA Anesthetics, Combined Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013