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Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

This study has been completed.
Sponsor:
Collaborators:
Mayday Fund
Pediatric Emergency Medicine Associates
Information provided by:
Georgia State University
ClinicalTrials.gov Identifier:
NCT00919100
First received: June 11, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OSBD-R observational pain/distress scale [ Time Frame: 5 minute ] [ Designated as safety issue: No ]
  • venipuncture success in one attempt [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919100

Locations
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
Investigators
Principal Investigator: Amy L Baxter, MD Children's Healthcare of Atlanta
Principal Investigator: Lindsey L Cohen, PhD Georgia State University
  More Information

No publications provided by Georgia State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amy Baxter, Pediatric Emergency Medicine Associates
ClinicalTrials.gov Identifier: NCT00919100     History of Changes
Other Study ID Numbers: 08007
Study First Received: June 11, 2009
Last Updated: June 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia State University:
pediatric
venipuncture
pain
vibration
vapocoolant

ClinicalTrials.gov processed this record on May 19, 2013