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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Pain Relief

Intervention / Treatment
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* Device: Buzzy® device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buzzy® device<br>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<br>* Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.<br>|
| No Intervention: No intervention<br>No intervention for pain relief | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success at first attempt | Percentage of success at first attempt | intraoperative | 
| Number of attempts required | Total number of attempts required | intraoperative | 
| Adverse events | The number and the type of adverse events will be recorded | up to 15 minutes after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phlebotomy, Intellectual Disability, Child, Buzzy, Procedural pain