Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement

NCT06182631 | Completed Phase 3 Results DMC FDA Drug FDA Device

• 1 other identifier: STUDY00002993
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intravenous Administration

Keywords

analgesic; anxiolytic; Buzzy Bee; Shot-blocker

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Vapocoolant

EXPERIMENTAL

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

Buzzy Bee

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Buzzy Bee DEVICE

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.

Buzzy Bee

Vapocoolent DRUG

Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.

Vapocoolant

Placebo OTHER

A band will be placed on the arm before IV insertion for placebo effect.

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Oshei Childrens Hospital

Buffalo, New York, 14203, United States

Location

Related Publications (9)

• 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.

  PMID: 22021341 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 9374583 BACKGROUND

• Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.

  PMID: 7636457 BACKGROUND

• 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.

  PMID: 11427329 BACKGROUND

• 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.

  PMID: 25935844 BACKGROUND

• 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.

  PMID: 5320816 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19781433 BACKGROUND

Results Point of Contact

• Title: Jill Fenenll
• Organization: SUNY Buffalo

jillfenn@buffalo.edu

716-323-0220

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: December 27, 2023
• Study Start: July 15, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: October 2, 2025
• Results First Posted: January 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)