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

NCT ID: NCT02434731

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Buzzy® device

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.

Group Type: EXPERIMENTAL

Buzzy® device

Intervention Type: DEVICE

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

No intervention

No intervention for pain relief

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Buzzy® device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Ronfani Luca

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Egidio Barbi, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo, Trieste, Italy

Silvana Schreiber, RN

Role: STUDY_DIRECTOR

IRCCS Burlo Garofolo, Trieste, Italy

Giorgio Cozzi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Burlo Garofolo, Trieste, Italy

Locations

IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 26401633 (View on PubMed)

Other Identifiers

RC 20/13

Identifier Type: -

Identifier Source: org_study_id