Clinical trial NCT02434731: Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Relief
Keywords: Procedural pain
Phlebotomy
Intellectual Disability
Child
Buzzy
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 71
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Pain score (NCCPC-PV scale)
timeFrame: intraoperative
Secondary outcomes:
measure: Success at first attempt
timeFrame: intraoperative
measure: Number of attempts required
timeFrame: intraoperative
measure: Adverse events
timeFrame: up to 15 minutes after the procedure
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
state: Friuli Venezia Giulia
Study officials:
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Egidio Barbi, MD
role: STUDY_CHAIR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Silvana Schreiber, RN
role: STUDY_DIRECTOR
affiliation: IRCCS Burlo Garofolo, Trieste, Italy
name: Giorgio Cozzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.