None listed
Conditions
Brief summary
Newborn infants admitted to a neonatal intensive care unit (NICU) are exposed to multiple episodes of painful stimuli. These are in the form of heel-prick blood sampling, venepuncture, intravenous line insertion and injections. Cold and mechanical distraction methods such as Buzzy® have been trialled in older children as a non-pharmacological method to reduce pain by the gate control mechanism. This study aims to investigate the efficacy of Buzzy® to reduce pain felt by newborn infants from and heel-prick blood sampling. For this study, only the vibration component will be used. The device will be attached prior to heel prick and activated according to the randomisation arm. Video recording of the entire event pre, during and post procedure for a total duration of 10min, will be taken and assessed by experts blinded to the intervention for documenting pain scores and analysing the difference if any.
Interventions
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 medic
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
Sponsors
Perth Childrens Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
1. Infants > 35 weeks gestational age and > 2.5kg 2. Needing a heel prick blood sample as part of routine care
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.
Outcome results
None listed