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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No intervention | No Intervention | No intervention for pain relief |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy® device | Device | Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Success at first attempt | Percentage of success at first attempt | intraoperative |
| Number of attempts required | Total number of attempts required |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Burlo Garofolo | Trieste | Friuli Venezia Giulia | 34137 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26401633 | Derived | 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. |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D008607 | Intellectual Disability |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| intraoperative |
| Adverse events | The number and the type of adverse events will be recorded | up to 15 minutes after the procedure |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |