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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
Results First Posted : September 18, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Mayday Fund
Information provided by (Responsible Party):
Lindsey L Cohen, PhD, 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.


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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 (FPS-R) [ Time Frame: 5 minute ]
    Self-report measure of pain via 6 faces ranging from neutral to increasing pain expression. The scoring for the scale ranges from 0-10 with lower scores representing lower pain and higher scores representing higher pain. The FPS-R was conducted several minutes following venipuncture. This time was not tracked, but it was typically between 2-5 minutes following completion of the venipuncture.


Secondary Outcome Measures :
  1. OSBD-R Observational Pain/Distress Scale [ Time Frame: 5 minute ]
    The Observational Scale of Behavioral Distress (OSBD) is a validated and commonly used scale. There are 11 OSBD distress responses (information seeking, cry, scream, physical restraint, verbal resistance, seeking emotional support, verbal pain, flail, verbal fear, muscular rigidity, and nervous behavior). Using videotapes of the venipuncture, a composite OSBD score of 1 (low distress) to 11 (high distress) was assigned from the time of placement of tourniquet to placement of the bandage or securing the intravenous line (IV) after the first attempt. Two students not associated with the hospital or the device had been previously trained in this methodology and coded all tapes. A supervisor assessed interrater reliability on each coded behavior. After each group of 10 subjects, interrater agreements that fell below the level of excellent agreement (kappa = 0.80) were reviewed and discussed by both coders, with the consensus score recorded and definitions of observed behaviors.

  2. Number of Participants With 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
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United States, Georgia
Children's Healthcare of Atlanta, Scottish Rite
Atlanta, Georgia, United States, 30342
Sponsors and Collaborators
Georgia State University
Mayday Fund
Investigators
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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):
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Responsible Party: Lindsey L Cohen, PhD, Principal Investigator, Georgia State University
ClinicalTrials.gov Identifier: NCT00919100     History of Changes
Other Study ID Numbers: CON007573
First Posted: June 12, 2009    Key Record Dates
Results First Posted: September 18, 2018
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Willing to share deidentified data with anyone interested in similar research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lindsey L Cohen, PhD, Georgia State University:
pediatric
venipuncture
pain
vibration
vapocoolant