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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434731
• Other study ID #: RC 20/13
• Status: Completed
• Phase: Phase 3
• First received: April 27, 2015
• Last updated: August 5, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Intellectual Disability
• Pain Relief

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

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