Clinical trial NCT06182631: Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement
Official title: A Randomized Clinical Trial of Buzzy Versus Vapocoolant in Pain Relief During Phlebotomy and IV Catheterization in the Pediatric ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intravenous Administration
Keywords: analgesic
anxiolytic
Buzzy Bee
Shot-blocker
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 172
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in Sensation of Pain Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
timeFrame: 20 minutes
measure: Perceived Change in Sensation of Pain During IV by Parent or Care-giver
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Oshei Childrens Hospital
state: New York
Study officials:
References:
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