Buzzy bee vibration and cold for easing pain and fear during elbow pin removal
Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal
We will test whether the Buzzy vibrating ice-pack can reduce pain and fear for children ages 3 to 10 during elbow pin removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 2 sites (Oklahoma City, Oklahoma and 1 other locations) |
| Trial ID | NCT07520851 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind controlled trial will enroll children aged 3–10 who undergo percutaneous pinning for an elbow fracture. Participants will be assigned to receive the Buzzy vibrating cold device or a control intervention (flash cards) during pin removal. Pain will be measured with the Wong-Baker Faces Pain Rating and fear will be measured with the Children's Fear Scale, with ratings collected from the child, the parent, and the clinician removing the pins. The trial is conducted at OU Health Children's in Oklahoma City, Oklahoma.
Who should consider this trial
Good fit: Children aged 3 to 10 who have had percutaneous pinning for an elbow fracture and whose caregiver is present and can provide consent.
Not a fit: Children younger than 3 or older than 10, those unable to communicate or quantify their pain, or those without parental consent or a caregiver present would not benefit or be eligible.
Why it matters
Potential benefit: If successful, the Buzzy device could reduce pain and fear during pin removal, improving the experience for children and easing the procedure for families and clinicians.
How similar studies have performed: Similar vibration-plus-cold devices like the Buzzy have shown reductions in procedural pain in children for injections and blood draws, though their effect for elbow pin removal is less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * between 3 to 10 years old * undergoes percutaneous pinning of an elbow fracture Exclusion Criteria: * under age 3 or over age 10 * unable to quantify or express their pain * Lack of parental consent * Absence of caregiver during procedure
Where this trial is running
Oklahoma City, Oklahoma and 1 other locations
- OU Health Children's — Oklahoma City, Oklahoma, United States (Recruiting)
- OU Health — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Kacy Richburg, MD — University of Oklahoma
- Study coordinator: Kathy Edge, CRC
- Email: Kathy-edge@ou.edu
- Phone: 405-271-4426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.