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OpenTrials
Completed

NCT Number: NCT02434731

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

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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buzzy® device

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

IRCCS Burlo Garofolo

Other

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 5, 2015
Registry last updated
Aug 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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