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Completed

NCT Number: NCT00919100

Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

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

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Healthcare of Atlanta, Scottish Rite

Atlanta, Georgia, 30342, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buzzy

Device

"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 names: BuzzyR

vapocoolant

Other

venipuncture with vapocoolant spray offered

Other names: PainEase

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • Mayday Fund

Registry information

Official study title

Buzzy: An Integration of Vibration, Cold, and Distraction for Pediatric Needle Pain Relief

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 12, 2009
Registry last updated
Nov 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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