Pain Relief Clinical Trial
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.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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