Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

A Randomized Clinical Trial of Buzzy Versus Vapocoolant in Pain Relief During Phlebotomy and IV Catheterization in the Pediatric ED

The purpose of this study is to compare the anxiety and pain levels of patients when using Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.

Study Overview

• Status: Completed
• Conditions: Intravenous Administration
• Intervention / Treatment: Drug: Vapocoolent; Device: Buzzy Bee; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Oshei Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Need IV's line placement for IV fluids and/or phlebotomy

Exclusion Criteria:

• patients sensitive to cold i.e. Raynaud's
• critically ill patients
• mentally challenged patients
• GCS< 15
• Patient with altered sensation
• Patients needing more than one attempt at IV placement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vapocoolant; Will have nurse spray vapocoolant on the skin before IV insertion, will then videotape patient and ask them and parent to fill out FACES form.	Drug: Vapocoolent; Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.
Experimental: Buzzy Bee; Will have nurse put Buzzy Bee on arm before, and leave it on during IV insertion. Will then videotape patient and ask them and parent to fill out FACES form.	Device: Buzzy Bee; The Buzzy is a vibrating palm-sized device with removable ice wings developed by MMJ Labs Atlanta, GA. It uses Melzack and Wall's Gait Control theorywhich asserts that activation of non-nociceptive fibers can interfere with signals from pain fibers thereby inhibiting pain.
Placebo Comparator: Placebo; Will have nurse place a rubber band around arm before IV insertion. Will then videotape patient and ask them and parent to fill out FACES form.	Other: Placebo; A band will be placed on the arm before IV insertion for placebo effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent	Wong- Baker Faces Pain Scale with scores: scale is 0-10, with 0 being no pain and 10 maximum pain. The changes in pain between the treatment groups were analyzed using chi square and one-way ANOVA for categorical and continuous variables respectively. Pre and post FACES pain scale-revised were reported as means and standard deviations	post intervention
Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver	Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain.	post intervention

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo

Publications and helpful links

General Publications

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.
• Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1.
• Cohen Reis E, Holubkov R. Vapocoolant spray is equally effective as EMLA cream in reducing immunization pain in school-aged children. Pediatrics. 1997 Dec;100(6):E5. doi: 10.1542/peds.100.6.e5.
• Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.
• Shah V, Taddio A, Rieder MJ; HELPinKIDS Team. Effectiveness and tolerability of pharmacologic and combined interventions for reducing injection pain during routine childhood immunizations: systematic review and meta-analyses. Clin Ther. 2009;31 Suppl 2:S104-51. doi: 10.1016/j.clinthera.2009.08.001.
• Lunoe MM, Drendel AL, Levas MN, Weisman SJ, Dasgupta M, Hoffmann RG, Brousseau DC. A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children. Ann Emerg Med. 2015 Nov;66(5):466-74. doi: 10.1016/j.annemergmed.2015.04.003. Epub 2015 Apr 29.
• Bijttebier P, Vertommen H. The Impact of Previous Experience on Children's Reactions to Venepunctures. J Health Psychol. 1998 Jan;3(1):39-46. doi: 10.1177/135910539800300103.
• Blount R. L., Zempsky W. T., Jaaniste T., Evans S., Cohen L. L., Devine K. A., Zeltzer L. K. Management of pain and distress due to medical procedures. In: Roberts M C, Steele R, editors. Handbook of pediatric psychology. 4th Ed. New York: Guilford Press; 2009. pp. 171-188.
• Pate J.T., Blount R.L., Cohen L.L. & Smith A.J. (1996). Childhood medical experience and temperament as predictors of adult functioning in medical situations. Child Health Care, 25 (4): 281-298.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: analgesic; anxiolytic; Buzzy Bee; Shot-blocker
• Additional Relevant MeSH Terms: Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: STUDY00002993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes