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

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02434731
Enrollment
71
Registered
2015-05-05
Start date
2015-04-30
Completion date
2015-06-30
Last updated
2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Relief

Keywords

Procedural pain, Phlebotomy, Intellectual Disability, Child, Buzzy

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.

Interventions

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

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pain score (NCCPC-PV scale)intraoperativeThe 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

MeasureTime frameDescription
Success at first attemptintraoperativePercentage of success at first attempt
Number of attempts requiredintraoperativeTotal number of attempts required
Adverse eventsup to 15 minutes after the procedureThe number and the type of adverse events will be recorded

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026