MedPath

Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

Not Applicable
Completed
Conditions
Pain
Interventions
Other: vapocoolant
Device: Buzzy
Registration Number
NCT00919100
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
81
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard Carevapocoolantvenipuncture with vapocoolant spray offered
BuzzyBuzzyVibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.
Primary Outcome Measures
NameTimeMethod
Faces Pain Scale-Revised (FPS-R)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
NameTimeMethod
Number of Participants With Venipuncture Success in One Attempt5 minutes
OSBD-R Observational Pain/Distress Scale5 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.

Trial Locations

Locations (1)

Children's Healthcare of Atlanta, Scottish Rite

🇺🇸

Atlanta, Georgia, United States

© Copyright 2025. All Rights Reserved by MedPath