Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

Study Overview
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Brief Summary
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The purpose of this study is to compare the anxiety and pain levels of patients when using Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.

Official Title
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A Randomized Clinical Trial of Buzzy Versus Vapocoolant in Pain Relief During Phlebotomy and IV Catheterization in the Pediatric ED

Conditions
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Intravenous Administration

Intervention / Treatment
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* Device: Buzzy Bee
* Drug: Vapocoolent
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need IV's line placement for IV fluids and/or phlebotomy Exclusion Criteria: patients sensitive to cold i.e. Raynaud's critically ill patients mentally challenged patients GCS< 15 Patient with altered sensation Patients needing more than one attempt at IV placement

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vapocoolant<br>Will have nurse spray vapocoolant on the skin before IV insertion, will then videotape patient and ask them and parent to fill out FACES form. | Drug: Vapocoolent<br>* Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.<br>|
| Experimental: Buzzy Bee<br>Will have nurse put Buzzy Bee on arm before, and leave it on during IV insertion. Will then videotape patient and ask them and parent to fill out FACES form. | Device: Buzzy Bee<br>* The Buzzy is a vibrating palm-sized device with removable ice wings developed by MMJ Labs Atlanta, GA. It uses Melzack and Wall's Gait Control theorywhich asserts that activation of non-nociceptive fibers can interfere with signals from pain fibers thereby inhibiting pain.<br>|
| Placebo Comparator: Placebo<br>Will have nurse place a rubber band around arm before IV insertion. Will then videotape patient and ask them and parent to fill out FACES form. | Other: Placebo<br>* A band will be placed on the arm before IV insertion for placebo effect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased sensation of pain based on Wong-Baker Pain Scale during IV placement with Buzzy bee or vapocoolent | Wong- Baker Faces Pain Scale with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. | 1 year | 
| Perceived decreased sensation of pain during IV by parent or care-giver | Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesic, anxiolytic, Buzzy Bee, Shot-blocker