Vibration and Cold for Pain Relief During Peripheral Intravenous Cannulation in Children With Intellectual Disability
|ClinicalTrials.gov Identifier: NCT02434731|
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : August 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Relief||Device: Buzzy® device||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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 Start Date :||April 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: 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.
Device: Buzzy® device
Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.
No Intervention: No intervention
No intervention for pain relief
- Pain score (NCCPC-PV scale) [ Time Frame: intraoperative ]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
- Success at first attempt [ Time Frame: intraoperative ]Percentage of success at first attempt
- Number of attempts required [ Time Frame: intraoperative ]Total number of attempts required
- Adverse events [ Time Frame: up to 15 minutes after the procedure ]The number and the type of adverse events will be recorded
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434731
|IRCCS Burlo Garofolo|
|Trieste, Friuli Venezia Giulia, Italy, 34137|
|Study Chair:||Egidio Barbi, MD||IRCCS Burlo Garofolo, Trieste, Italy|
|Study Director:||Silvana Schreiber, RN||IRCCS Burlo Garofolo, Trieste, Italy|
|Principal Investigator:||Giorgio Cozzi, MD||IRCCS Burlo Garofolo, Trieste, Italy|