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NCT01394250 · ClinicalTrials.gov registry record · Phase 2
Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
A Phase 2 study, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT01394250: Completed Phase 2 study, sponsored by Children's Hospital of Philadelphia.
NCT01394250 is a Phase 2 study that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 240 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01394250, a Phase 2 study, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical lidocaine cream in reducing the pain associated with IV cannulation.
Primary Outcome
The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10).
Interventions
- DEVICE Buzzy
- DRUG Topical Lidocaine 4% Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT01394250 record still lists
NCT01394250 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 2 interventions - of which Buzzy is the first listed.
NCT01394250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01394250 about?
NCT01394250 is a clinical study titled "Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief". The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical lidocaine cream in reducing...
What is the current status of trial NCT01394250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2011-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01394250?
The interventions under investigation include: Buzzy (DEVICE), Topical Lidocaine 4% Cream (DRUG).
Who is sponsoring clinical trial NCT01394250?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01394250's enrollment target sits among peer trials
240 239th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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