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.
Verified date | August 2015 |
Source | IRCCS Burlo Garofolo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 17 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Burlo Garofolo | Trieste | Friuli Venezia Giulia |
Lead Sponsor | Collaborator |
---|---|
IRCCS Burlo Garofolo |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score (NCCPC-PV scale) | 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 | intraoperative | No |
Secondary | Success at first attempt | Percentage of success at first attempt | intraoperative | No |
Secondary | Number of attempts required | Total number of attempts required | intraoperative | No |
Secondary | Adverse events | The number and the type of adverse events will be recorded | up to 15 minutes after the procedure | Yes |
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