Phase 3
N=171
Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement
Intravenous Administration
Bottom Line
View on ClinicalTrials.gov: NCT06182631 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent — 4.54; 5.41; 5.03; 3.84 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buzzy Bee (Device); Vapocoolent (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent |
4.54; 5.41; 5.03; 3.84; 3.58; 4.57 | — |
| PRIMARY Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver |
3.06; 3.46; 2.86; 2.24; 1.69; 2.79 | — |
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.
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
- GCS< 15
- Patient with altered sensation
- Patients needing more than one attempt at IV placement
Data sourced from ClinicalTrials.gov (NCT06182631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.