Intravenous AdministrationPhase 3NCT06182631
Clinical Trial Testing Buzzy Bee vs Vapocoolant During IV Placement
A Phase 3 study testing Buzzy Bee and Vapocoolent in people with Intravenous Administration, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Administration
- What is being tested?
- Buzzy Bee and Vapocoolent
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 15 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Need IV's line placement for IV fluids and/or phlebotomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Intravenous Administration
- Being tested
- Buzzy Bee, Vapocoolent, Placebo
- Keywords
- analgesic, anxiolytic, Buzzy Bee, Shot-blocker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy BeeDevice
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.
VapocoolentDrug
Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV.
PlaceboOther
A band will be placed on the arm before IV insertion for placebo effect.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start15 Jul 2019
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intravenous AdministrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill C Fennell, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182631
- Sponsor's protocol ID
- STUDY00002993
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2023
- Last updated
- 2 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22021341Blount 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.
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.
PubMed 9374583Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.
PubMed 7636457Hicks 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.
PubMed 11427329Lunoe 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.
PubMed 25935844Melzack 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.
PubMed 5320816Pate 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.
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.
PubMed 19781433
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Buzzy Versus Vapocoolant in Pain Relief During Phlebotomy and IV Catheterization in the Pediatric ED
- ClinicalTrials.gov ID
- NCT06182631
- Acronym / sponsor ID
- STUDY00002993
- Conditions
- Intravenous Administration
- Keywords
- analgesic, anxiolytic, Buzzy Bee, Shot-blocker
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vapocoolant | Experimental | Drug: VapocoolentWill have nurse spray vapocoolant on the skin before IV insertion, will then videotape patient and ask them and parent to fill out FACES form. |
| Buzzy Bee | Experimental | Device: Buzzy BeeWill 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. |
| Placebo | Placebo comparator | Other: PlaceboWill 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Need IV's line placement for IV fluids and/or phlebotomy
Key exclusion criteria (6 listed)
- patients sensitive to cold i.e. Raynaud's
- critically ill patients
- mentally challenged patients
- GCS< 15
- Patient with altered sensation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buzzy BeeThe 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. | Device | Buzzy Bee |
| VapocoolentVapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV. | Drug | Vapocoolant |
| PlaceboA band will be placed on the arm before IV insertion for placebo effect. | Other | Placebo |
Primary outcome
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent
Time frame: post intervention
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
Perceived FACES Pain Score in Sensation of Pain During IV by Parent or Care-giver
Time frame: post intervention
Faces Pain Scale revised with scores: scale is 0-10, with 0 being no pain and 10 maximum pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22021341Bijttebier 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.
- BackgroundBlount 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: PubMed 9374583Cohen 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.
- Background: PubMed 7636457Hamilton JG. Needle phobia: a neglected diagnosis. J Fam Pract. 1995 Aug;41(2):169-75.
- Background: PubMed 11427329Hicks 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.
- Background: PubMed 25935844Lunoe 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.
- Background: PubMed 5320816Melzack 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.
- BackgroundPate 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: PubMed 19781433Shah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buzzy Bee and Vapocoolent in people with Intravenous Administration, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Based on Wong-Baker Pain Scale During IV Placement With Buzzy Bee or Vapocoolent (time frame: post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182631, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.