Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability
- Conditions
- Pain Relief
- Interventions
- Device: Buzzy® device
- Registration Number
- NCT02434731
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- Age 4 to 17 years
- Presence of intellectual disability
- Need of peripheral IV line or venipuncture
- Informed consent signed by parents or legal guardians
- Presence of abrasion, infection or break in skin in the area of Buzzy® placement
- Cold hypersensibility
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Buzzy® device 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Number of attempts required intraoperative Total number of attempts required
Success at first attempt intraoperative Percentage of success at first attempt
Adverse events up to 15 minutes after the procedure The number and the type of adverse events will be recorded
Trial Locations
- Locations (1)
IRCCS Burlo Garofolo
🇮🇹Trieste, Friuli Venezia Giulia, Italy