Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

Phase 3

Completed

• Conditions: Intravenous Administration
• Interventions: Drug: Vapocoolent; Device: Buzzy Bee; Other: Placebo

• Registration Number: NCT06182631
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Primary Completion: 2021-01-15
• Study Completion: 2021-01-15
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-12-19
• Study First Posted: 2023-12-27
• Results First Submitted: 2024-07-18
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Results First Posted: 2025-01-15
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vapocoolant	Vapocoolent	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.
Buzzy Bee	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Sensation of Pain Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent	20 minutes	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 a 3 group ANOVA design, then least squares regression was utilized.
Perceived Change in Sensation of Pain During IV by Parent or Care-giver	20 minutes	Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain.

Trial Locations

Locations (1)

Oshei Childrens Hospital; 🇺🇸 Buffalo, New York, United States