75 Participants NeededMy employer runs this trial

Buzzy System for Elbow Fractures

Recruiting at 1 trial location
KE
CM
Overseen ByChristopher McCormick, BA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Buzzy System, a vibrating ice pack shaped like a bee, can reduce pain during pin removal from an elbow fracture. It compares two groups: one uses the Buzzy System with flash cards, while the other uses only flash cards for distraction. The trial seeks children aged 3 to 10 who have had a pin placed in their elbow due to a fracture. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques for children.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Buzzy System is safe for reducing pain in elbow fracture pin removal?

Research has shown that the Buzzy System is safe and effective for children. This bee-shaped device vibrates and cools to reduce pain and anxiety during procedures like shots. Over 90 studies have proven its effectiveness in pain reduction without causing harm. These studies have reported no major side effects, making it a promising method to ease discomfort in medical settings.12345

Why are researchers excited about this trial?

Researchers are excited about exploring the Buzzy System for elbow fractures because it offers a unique approach to managing pain and anxiety, especially in children. Unlike traditional pain relief methods like medications that can have side effects, the Buzzy System uses a buzzing ice pack combined with vibration to block pain signals and distract the brain. This non-invasive method could provide immediate relief without the need for drugs. Additionally, the use of flash cards as a parental distraction tool is being tested to see if it can further reduce anxiety during treatment. Together, these methods could make fracture treatment less stressful and more comfortable for young patients.

What evidence suggests that the Buzzy System is effective for reducing pain in elbow fracture pin removal?

Research has shown that the Buzzy System, a bee-shaped vibrating ice pack, can help reduce pain. In over 100 studies, 96% found that Buzzy significantly lowered pain levels. For example, it reduced pain in children during needle procedures like shots. The device uses cold and vibration to distract the brain from feeling pain. In this trial, one group will use the Buzzy System along with flash cards, while another group will use flash cards only. This approach makes the Buzzy System a promising method to ease the discomfort of removing pins from elbow fractures.12678

Who Is on the Research Team?

KR

Kacy Richburg, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for children aged 3 to 10 who are having pins removed after an elbow fracture. Kids must be able to describe their pain, have a caregiver present, and have parental consent.

Inclusion Criteria

I am between 3 and 10 years old.
I am having a pin placed in my elbow to treat a fracture.

Exclusion Criteria

Absence of caregiver during procedure
Lack of parental consent
I am younger than 3 or older than 10 years old.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo the procedure of elbow fracture pin removal with or without the Buzzy System and flash cards

Single session
1 visit (in-person)

Follow-up

Participants are monitored for pain and fear reduction immediately after the procedure

10 minutes
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Buzzy System

Trial Overview

The study compares using the Buzzy System (a vibrating ice pack shaped like a bee) versus flash cards to see which helps reduce pain and fear during pin removal from the elbow.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: 1Buzzy System with Flash CardsActive Control2 Interventions
Group II: 2 Flash Cards onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

Citations

Efficacy of the Buzzy System on Pain and Fear Reduction ...

A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A ...

Efficacy of the Buzzy System on Pain and Fear Reduction ...

The goal of this study is to determine if the Buzzy System, a vibrating ice pack shaped like a bee reduces pain in removal of elbow fracture pin.

Buzzing Away Pain: Efficacy of Buzzy® in Reducing ... - PMC

This study aimed to evaluate the effectiveness of Buzzy® in mitigating pain during subcutaneous administration of canakinumab in patients with FMF who are ...

Buzzy System for Elbow Fractures

The goal of this study is to determine if the Buzzy System, a vibrating ice pack shaped like a bee reduces pain in removal of elbow fracture ...

5.

paincarelabs.com

paincarelabs.com/science

Pain Relief Research

Clinical Trials. Of >100 prospective randomized trials, 96% showed statistically significant pain relief. Buzzy is the only needle intervention shown to reduce ...

Effectiveness and safety of Buzzy device in needle-related ...

The Buzzy device reduces pain and anxiety in children during needle procedures, ensuring success and safety.

Efficacy of the Buzzy System on Pain and Fear Reduction ...

Brief Summary: The goal of this study is to determine if the Buzzy System, a vibrating ice pack shaped like a bee reduces pain in removal of ...

DANNY VAN LEEUWEN, OPA, RN, MPH (Health Hats)

Over 90 prospective randomized controlled trials with the Buzzy device demonstrate significant a-delta pain reduction. The VibraCool device ...