Buzzy Versus Vapocoolant Spray: Pediatric Needle Pain Relief

NCT00919100 | Completed Results DMC FDA Device

• 1 other identifier: CON007573
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

pediatric; venipuncture; pain; vibration; vapocoolant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• OSBD-R Observational Pain/Distress Scale

  5 minute

• Number of Participants With Venipuncture Success in One Attempt

  5 minutes

Study Arms (2)

Standard Care

OTHER

venipuncture with vapocoolant spray offered

Other: vapocoolant

Buzzy

EXPERIMENTAL

Vibrating device with cold pack held to arm with tourniquet proximal to venipuncture site, optional distraction cards.

Device: Buzzy

Interventions

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.

Also known as: BuzzyR

Buzzy

vapocoolant OTHER

venipuncture with vapocoolant spray offered

Also known as: PainEase

Standard Care

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients requiring venipuncture in a pediatric emergency department
• Informed consent
• Patient assent

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead
• Mayday Fund: collaborator

Study Sites (1)

Children's Healthcare of Atlanta, Scottish Rite

Atlanta, Georgia, 30342, United States

Location

Related Publications (1)

• 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.

  PMID: 22134226 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Amy Baxter
• Organization: MMJ Labs

abaxter@mmjlabs.com

877-805-2899

Study Officials

• Amy L Baxter, MD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

• Lindsey L Cohen, PhD

  Georgia State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: April 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 21, 2018
• Results First Posted: September 18, 2018

Record last verified: 2018-11

Locations

US (1)