Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement
NCT06182631 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172
Last updated 2025-10-02
Summary
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.
Conditions
- Intravenous Administration
Interventions
- DEVICE
-
Buzzy Bee
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.
- DRUG
-
Vapocoolent
Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.
- OTHER
-
Placebo
A band will be placed on the arm before IV insertion for placebo effect.
Sponsors & Collaborators
-
State University of New York at Buffalo
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-07-15
- Primary Completion
- 2021-01-15
- Completion
- 2021-01-15
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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