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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02434731
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : August 6, 2015
Information provided by (Responsible Party):
Ronfani Luca, IRCCS Burlo Garofolo

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

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Study Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Pain score (NCCPC-PV scale) [ Time Frame: 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 :
  1. Success at first attempt [ Time Frame: intraoperative ]
    Percentage of success at first attempt

  2. Number of attempts required [ Time Frame: intraoperative ]
    Total number of attempts required

  3. Adverse events [ Time Frame: up to 15 minutes after the procedure ]
    The number and the type of adverse events will be recorded

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02434731

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IRCCS Burlo Garofolo
Trieste, Friuli Venezia Giulia, Italy, 34137
Sponsors and Collaborators
IRCCS Burlo Garofolo
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ronfani Luca, MD, PhD, IRCCS Burlo Garofolo Identifier: NCT02434731    
Other Study ID Numbers: RC 20/13
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Keywords provided by Ronfani Luca, IRCCS Burlo Garofolo:
Procedural pain
Intellectual Disability
Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders