Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000372482p
Ethics application status
Submitted, not yet approved
Date submitted
11/02/2025
Date registered
28/04/2025
Date last updated
28/04/2025
Date data sharing statement initially provided
28/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Buzzy Bee for Pain in Babies
Scientific title
Effect of Buzzy® on neonatal pain from heel-prick blood sampling: A randomised controlled trial.
Secondary ID [1] 313225 0
none
Universal Trial Number (UTN)
Trial acronym
B4B Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain 335523 0
Condition category
Condition code
Anaesthesiology 332092 332092 0 0
Pain management
Public Health 333344 333344 0 0
Health service research
Reproductive Health and Childbirth 333345 333345 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate the efficacy of Buzzy® to reduce pain felt by newborn infants from heel-prick blood sampling. BUZZY® was developed by Dr Amy Baxter, a paediatric emergency physician and pain researcher. It is a small vibrating bee with blue ice-pack wings. For this study only the vibration component will be used. The ice wings will NOT be used as infants may experience more discomfort with cold sensation as well.
It is FDA approved. It is a multi-patient use device made from medical-grade plastic and can withstand medical grade cleaners and can be fully sanitised between patients. It is 7.5cm X 5cm in size.

After randomisation, the infant will have the BUZZY system attached prior to blood sampling. The Buzzy® will be held to lie on the postero-medial aspect of the calf and thigh to target the tibial nerve distribution if the heel-prick is to be over the medial aspect of the heel or the postero-lateral aspect of the calf and thigh to target the sural nerve distribution if the heelprick is to be over the lateral aspect of the heel.

A video recording will commence just after the BUZZY system is attached and continue for at least 2 minute after blood sample.

The intervention group will have the BUZZY system turned on at least 30 seconds prior to blood sampling. If the parents had consented to sucrose, infants in both the intervention and non-intervention groups will receive a dose as per the protocol prior to blood sampling.

Blood sampling procedure will be performed as per the NICU protocol and pre-sampling and post-sampling routine care will be the same. The only difference will be the BUZZY system will be kept on for 30 seconds after the blood has been taken.

The video will be discontinued and pain will be scored at a later time, separately by two independent research team members
Intervention code [1] 329817 0
Treatment: Devices
Comparator / control treatment
BUZZY system attached but the vibration component will not be activated used during blood sampling. Both groups will receive sucrose for pain management per protocol.
Control group
Placebo

Outcomes
Primary outcome [1] 339700 0
Perceived pain in newborn infants that require heel-prick blood sampling
Timepoint [1] 339700 0
Anonymised video recording of the baby would be assessed for scoring pain by a blinded expert.
Secondary outcome [1] 440938 0
Skin breakdown or redness
Timepoint [1] 440938 0
Immediately after use and within first 48hours of device application.

Eligibility
Key inclusion criteria
1. Infants > 35 weeks gestational age and > 2.5kg

2. Needing a heel prick blood sample as part of routine care
Minimum age
No limit
Maximum age
28 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intubated infants
2. Infants that are on or have received sedatives in the last 48 hours (midazolam, phenobarbital, dexmedetomidine, clonidine)
3. Infants that are on or have received analgesics in the last 48 hours (opiates, paracetamol)
4. Infants with neurological conditions with altered level of consciousness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/11/2025
Actual
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27627 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 43800 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 317667 0
Hospital
Name [1] 317667 0
Perth Children's Hospital
Country [1] 317667 0
Australia
Primary sponsor type
Hospital
Name
Perth Childrens Hospital
Address
Country
Australia
Secondary sponsor category [1] 319983 0
None
Name [1] 319983 0
Address [1] 319983 0
Country [1] 319983 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316367 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 316367 0
Ethics committee country [1] 316367 0
Australia
Date submitted for ethics approval [1] 316367 0
31/03/2025
Approval date [1] 316367 0
Ethics approval number [1] 316367 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137666 0
Dr Jason Tan
Address 137666 0
Ward 3b, Perth Children's Hospital 15 Hospital Avenue, Nedlands 6009 Perth Western Australia
Country 137666 0
Australia
Phone 137666 0
+61864563458
Fax 137666 0
Email 137666 0
[email protected]
Contact person for public queries
Name 137667 0
Jason Tan
Address 137667 0
Ward 3b, Perth Children's Hospital 15 Hospital Avenue, Nedlands 6009 Perth Western Australia
Country 137667 0
Australia
Phone 137667 0
+61864563458
Fax 137667 0
Email 137667 0
[email protected]
Contact person for scientific queries
Name 137668 0
Dr. Jason Tan
Address 137668 0
Ward 3b, Perth Children's Hospital 15 Hospital Avenue, Nedlands 6009 Perth Western Australia
Country 137668 0
Australia
Phone 137668 0
+61864563458
Fax 137668 0
Email 137668 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.