Trials / Completed
CompletedNCT00919100
Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief
Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Georgia State University · Academic / Other
- Sex
- All
- Age
- 4 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.
Detailed description
Needle pain is the most common and the most feared source of childhood pain, resulting in needle phobia for 10% of adults. Current pain relief options include numbing creams, vapocoolant spray, or injected lidocaine. 17 million pediatric IV access procedures are done yearly with no pain intervention. An inexpensive, immediately acting form of needle pain control could reduce needle phobia in the long term if demonstrated to be effective for needle pain. This study will evaluate pain self report and parent report using the Faces Pain Scale revised, and video-coded OSBD-R scores for patients undergoing emergency department venous access or cannulation procedures. Demographic information, pre-procedural anxiety, and success data from the attempts at placement will be included.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Buzzy | "Buzzy" is a vibrating cold pack attached with Velcro strap or tourniquet 5-10cm proximal to the site of venipuncture. The vibration is activated and the device remains in place throughout the procedure. The distraction cards are offered to the parents to show the children, with questions on the back and pictures on the front. |
| OTHER | vapocoolant | venipuncture with vapocoolant spray offered |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2008-08-01
- Completion
- 2008-08-01
- First posted
- 2009-06-12
- Last updated
- 2018-11-21
- Results posted
- 2018-09-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT00919100. Inclusion in this directory is not an endorsement.