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Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability

Primary Purpose

Pain Relief

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Buzzy® device
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain Relief focused on measuring Procedural pain, Phlebotomy, Intellectual Disability, Child, Buzzy

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 4 to 17 years
  • Presence of intellectual disability
  • Need of peripheral IV line or venipuncture
  • Informed consent signed by parents or legal guardians

Exclusion Criteria:

  • Presence of abrasion, infection or break in skin in the area of Buzzy® placement
  • Cold hypersensibility

Sites / Locations

  • IRCCS Burlo Garofolo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Buzzy® device

No intervention

Arm Description

The Buzzy® device will be applied just above the selected site of the venipuncture; a ice pack will be attached under the device; the device will be turned on and after 15 second the procedure will be carried out.

No intervention for pain relief

Outcomes

Primary Outcome Measures

Pain score (NCCPC-PV scale)
The pain during the procedure will be evaluated using the NCCPC-PV scale (Non-communicating Children's Pain Checklist - Postoperative Version) administered by a nurse

Secondary Outcome Measures

Success at first attempt
Percentage of success at first attempt
Number of attempts required
Total number of attempts required
Adverse events
The number and the type of adverse events will be recorded

Full Information

First Posted
April 27, 2015
Last Updated
August 5, 2015
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT02434731
Brief Title
Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability
Official Title
Randomized Controlled Trial to Evaluate the Effectiveness of Vibration and External Cold (Buzzy Device) for Pain Relief During Venipuncture or Intravenous Cannulation in Children With Intellectual Disability.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Needle procedures are the most common and important source of pain and distress in children in the health care setting. Children with intellectual disability from any cause experience pain more frequently than healthy children. They often require venipuncture or IV cannulation for diagnostic or therapeutic procedures. Pain in this population is often unrecognised because these patients are frequently unable to self-report their pain. Now it's possible to measure pain in children with intellectual disability with specific pain scales, like NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version). The efficacy of a device combining vibration and cold for pain relief during venipuncture or IV cannulation has been recently reported in children. The device's actions are based on the Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in this kind of patients in emergency department. To date, there is no study that validated Buzzy device for pain relief in children with intellectual disability. The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and vibration), in reducing the pain during venipuncture or IV cannulation, in children with intellectual disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Relief
Keywords
Procedural pain, Phlebotomy, Intellectual Disability, Child, Buzzy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buzzy® device
Arm Type
Experimental
Arm Description
The Buzzy® device will be applied just above the selected site of the venipuncture; a ice pack will be attached under the device; the device will be turned on and after 15 second the procedure will be carried out.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention for pain relief
Intervention Type
Device
Intervention Name(s)
Buzzy® device
Intervention Description
Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.
Primary Outcome Measure Information:
Title
Pain score (NCCPC-PV scale)
Description
The pain during the procedure will be evaluated using the NCCPC-PV scale (Non-communicating Children's Pain Checklist - Postoperative Version) administered by a nurse
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Success at first attempt
Description
Percentage of success at first attempt
Time Frame
intraoperative
Title
Number of attempts required
Description
Total number of attempts required
Time Frame
intraoperative
Title
Adverse events
Description
The number and the type of adverse events will be recorded
Time Frame
up to 15 minutes after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 4 to 17 years Presence of intellectual disability Need of peripheral IV line or venipuncture Informed consent signed by parents or legal guardians Exclusion Criteria: Presence of abrasion, infection or break in skin in the area of Buzzy® placement Cold hypersensibility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egidio Barbi, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Silvana Schreiber, RN
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giorgio Cozzi, MD
Organizational Affiliation
IRCCS Burlo Garofolo, Trieste, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Burlo Garofolo
City
Trieste
State/Province
Friuli Venezia Giulia
ZIP/Postal Code
34137
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
26401633
Citation
Schreiber S, Cozzi G, Rutigliano R, Assandro P, Tubaro M, Cortellazzo Wiel L, Ronfani L, Barbi E. Analgesia by cooling vibration during venipuncture in children with cognitive impairment. Acta Paediatr. 2016 Jan;105(1):e12-6. doi: 10.1111/apa.13224. Epub 2015 Nov 4.
Results Reference
derived

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Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability

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