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Clinical Trials/NCT06182631
NCT06182631
Completed
Phase 3

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

State University of New York at Buffalo1 site in 1 country172 target enrollmentJuly 15, 2019

Overview

Phase
Phase 3
Intervention
Vapocoolent
Conditions
Intravenous Administration
Sponsor
State University of New York at Buffalo
Enrollment
172
Locations
1
Primary Endpoint
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
Status
Completed
Last Updated
7 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 15, 2019
End Date
January 15, 2021
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jill C Fennell

Pediatric Emergency Medicine Fellow

State University of New York at Buffalo

Eligibility Criteria

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
  • Patient with altered sensation
  • Patients needing more than one attempt at IV placement

Arms & Interventions

Vapocoolant

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.

Intervention: Vapocoolent

Buzzy Bee

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.

Intervention: Buzzy Bee

Placebo

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.

Intervention: Placebo

Outcomes

Primary Outcomes

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

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.

Study Sites (1)

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