This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

This study has been completed.
Mayday Fund
Pediatric Emergency Medicine Associates
Information provided by:
Georgia State University Identifier:
First received: June 11, 2009
Last updated: March 9, 2015
Last verified: June 2009
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.

Condition Intervention
Pain Device: Buzzy Other: vapocoolant

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief

Further study details as provided by Georgia State University:

Primary Outcome Measures:
  • Faces Pain Scale-Revised [ Time Frame: 5 minute ]

Secondary Outcome Measures:
  • OSBD-R observational pain/distress scale [ Time Frame: 5 minute ]
  • venipuncture success in one attempt [ Time Frame: 5 minutes ]

Enrollment: 81
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Care
venipuncture with vapocoolant spray offered
Other: vapocoolant
venipuncture with vapocoolant spray offered
Other Name: PainEase
Experimental: Buzzy
Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.
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 Name: BuzzyR

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.


Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients requiring venipuncture in a pediatric emergency department
  • Informed consent
  • Patient assent

Exclusion criteria:

  • Patients with sickle cell or other sensitivity to cold
  • Nerve damage in the area
  • Abrasion or break in skin where device would be placed
  • Critically ill
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00919100

United States, Georgia
Children's Healthcare of Atlanta, Scottish Rite
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Georgia State University
Mayday Fund
Pediatric Emergency Medicine Associates
Principal Investigator: Amy L Baxter, MD Children's Healthcare of Atlanta
Principal Investigator: Lindsey L Cohen, PhD Georgia State University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Amy Baxter, Pediatric Emergency Medicine Associates Identifier: NCT00919100     History of Changes
Other Study ID Numbers: 08007
Study First Received: June 11, 2009
Last Updated: March 9, 2015

Keywords provided by Georgia State University:
vapocoolant processed this record on September 25, 2017