NCT06182631

Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-07-15
• Primary completion: 2021-01-15
• Completion: 2021-01-15
• First posted: 2023-12-27
• Last updated: 2025-10-02
• Results posted: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study