Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

Buzzy: An Integration of Vibration, Cold, and Distraction for 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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: vapocoolant; Device: Buzzy

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
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Healthcare of Atlanta, Scottish Rite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Standard Care; venipuncture with vapocoolant spray offered	Other: vapocoolant; venipuncture with vapocoolant spray offered; Other Names: 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 Names: BuzzyR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faces Pain Scale-Revised (FPS-R)	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.	5 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSBD-R Observational Pain/Distress Scale	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.	5 minute
Number of Participants With Venipuncture Success in One Attempt		5 minutes

Collaborators and Investigators

• Sponsor: Georgia State University
• Collaborators: Mayday Fund
• Investigators: Principal Investigator: Amy L Baxter, MD, Children's Healthcare of Atlanta; Principal Investigator: Lindsey L Cohen, PhD, Georgia State University

Publications and helpful links

General Publications

• Baxter AL, Cohen LL, McElvery HL, Lawson ML, von Baeyer CL. An integration of vibration and cold relieves venipuncture pain in a pediatric emergency department. Pediatr Emerg Care. 2011 Dec;27(12):1151-6. doi: 10.1097/PEC.0b013e318237ace4.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): August 1, 2008
• Study Completion (ACTUAL): August 1, 2008

Study Registration Dates

• First Submitted: June 11, 2009
• First Submitted That Met QC Criteria: June 11, 2009
• First Posted (ESTIMATE): June 12, 2009

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: pain; pediatric; venipuncture; vibration; vapocoolant
• Other Study ID Numbers: CON007573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Willing to share deidentified data with anyone interested in similar research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No