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

Sponsor

IRCCS Burlo Garofolo (Other)

Overall Status

Completed

CT.gov ID

NCT02434731

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

35.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Relief	Device: Buzzy® device	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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 Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buzzy® device 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.	Device: Buzzy® device Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.
No Intervention: No intervention No intervention for pain relief

Arm

Intervention/Treatment

Experimental: Buzzy® device

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.

Device: Buzzy® device

Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.

No Intervention: No intervention

No intervention for pain relief

Outcome Measures

Primary Outcome Measures

Pain score (NCCPC-PV scale) [intraoperative]
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 [intraoperative]
Percentage of success at first attempt
Number of attempts required [intraoperative]
Total number of attempts required
Adverse events [up to 15 minutes after the procedure]
The number and the type of adverse events will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia	Italy	34137

Sponsors and Collaborators

IRCCS Burlo Garofolo

Investigators

Study Chair: Egidio Barbi, MD, IRCCS Burlo Garofolo, Trieste, Italy
Study Director: Silvana Schreiber, RN, IRCCS Burlo Garofolo, Trieste, Italy
Principal Investigator: Giorgio Cozzi, MD, IRCCS Burlo Garofolo, Trieste, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo

ClinicalTrials.gov Identifier:

NCT02434731

Other Study ID Numbers:

RC 20/13

First Posted:

May 5, 2015

Last Update Posted:

Aug 6, 2015

Last Verified:

Aug 1, 2015

Keywords provided by Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo

Procedural pain

Phlebotomy

Intellectual Disability

Child

Buzzy

Additional relevant MeSH terms:

Intellectual Disability

Study Results

No Results Posted as of Aug 6, 2015