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Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

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ClinicalTrials.gov Identifier: NCT00919100
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : March 10, 2015
Sponsor:
Collaborators:
Mayday Fund
Pediatric Emergency Medicine Associates
Information provided by:
Georgia State University

Brief Summary:
A vibrating cold pack placed proximal to the site of venipuncture will decrease the pain of cannulation when compared to vapocoolant spray.

Condition or disease Intervention/treatment Phase
Pain Device: Buzzy Other: vapocoolant Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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
Study Start Date : April 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: March 10, 2015
Last Verified: June 2009

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