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Completed

NCT Number: NCT06182631

Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

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.

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Key information

Conditions

Intravenous Administration

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Oshei Childrens Hospital

Buffalo, New York, 14203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buzzy Bee

Device

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.

Vapocoolent

Drug

Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.

Placebo

Other

A band will be placed on the arm before IV insertion for placebo effect.

Primary outcomes

  1. Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent

    Time frame: post intervention

    Wong- Baker Faces Pain Scale with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. The changes in pain between the treatment groups were analyzed using chi square and one-way ANOVA for categorical and continuous variables respectively. Pre and post FACES pain scale-revised were reported as means and standard deviations

  2. Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver

    Time frame: post intervention

    Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 27, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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