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

NCT02434731 | Completed Phase 3

• 1 other identifier: RC 20/13
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Relief

Keywords

Procedural pain; Phlebotomy; Intellectual Disability; Child; Buzzy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Success at first attempt

  intraoperative

• Number of attempts required

  intraoperative

• Adverse events

  up to 15 minutes after the procedure

Study Arms (2)

Buzzy® device

EXPERIMENTAL

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.

Device: Buzzy® device

No intervention

NO INTERVENTION

No intervention for pain relief

Interventions

Buzzy® device DEVICE

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

Buzzy® device

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4 to 17 years
• Presence of intellectual disability
• Need of peripheral IV line or venipuncture
• Informed consent signed by parents or legal guardians

You may not qualify if:

• Presence of abrasion, infection or break in skin in the area of Buzzy® placement
• Cold hypersensibility

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

Related Publications (1)

• Schreiber S, Cozzi G, Rutigliano R, Assandro P, Tubaro M, Cortellazzo Wiel L, Ronfani L, Barbi E. Analgesia by cooling vibration during venipuncture in children with cognitive impairment. Acta Paediatr. 2016 Jan;105(1):e12-6. doi: 10.1111/apa.13224. Epub 2015 Nov 4.

  PMID: 26401633 DERIVED

MeSH Terms

Conditions

Pain, Procedural; Intellectual Disability

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Egidio Barbi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY CHAIR

• Silvana Schreiber, RN

  IRCCS Burlo Garofolo, Trieste, Italy

  STUDY DIRECTOR

• Giorgio Cozzi, MD

  IRCCS Burlo Garofolo, Trieste, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 5, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 6, 2015

Record last verified: 2015-08

Locations

IT (1)