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

IRCCS Burlo Garofolo

Status and phase: Completed; Phase 3

Conditions: Pain Relief

Treatments: Device: Buzzy® device

Study type: Interventional

Funder types: Other

Identifiers

NCT02434731

RC 20/13

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Buzzy® device

Experimental group

Description:

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.

Treatment:

Device: Buzzy® device

No intervention

No Intervention group

Description:

No intervention for pain relief