Infant pain-monitoring device gains international approval

PainChek’s pain-assessment tool for infants has received several regulatory clearances that now allow sales and marketing in Australia, Europe, the UK, Canada, Singapore and New Zealand.

The regulatory clearances — including those from the Therapeutic Goods Administration (TGA) and the UK MHRA as well as the CE mark — follow completion of PainChek’s Infant Face-Only study, which supports the clinical indication for use of the device in procedural pain assessment. PainChek Infant is now cleared for use with infants aged between one and 12 months.

The smartphone-based pain assessment and monitoring application has potential for use in children’s hospitals and postnatal wards, and among parents and other healthcare professionals.

The PainChek Infant Face-Only study was developed to test the feasibility of using PainChek Infant’s face domain alone as an indicator of pain, and to evaluate it using video recordings of infants undergoing painful procedures. The study involved PainChek Infant face domain scores being compared with assessments conducted using the Revised Neonatal Facial Coding System (NFCS-R) and the Observer Visual Analogue Scale (ObsVAS). Both NFCS-R and ObsVAS are well-known and validated scales used in assessing procedural pain in infants, such as vaccinations, finger and heel pricks, dressing changes or more invasive procedures such as biopsies. Findings from the study supported the validity and reliability of PainChek Infant for procedural pain assessment. Procedural pain represents a significant problem as it can have both short-term and long-term negative consequences on children’s health if not managed effectively.

With 400 million pre-verbal children in the world — 100 million of whom are estimated to be born to first-time parents — PainChek Infant has a large market opportunity.

PainChek will continue to develop clinical applications and broaden the age ranges for children’s pain assessment through additional research and clinical studies, including the existing study at The Royal Children’s Hospital (RCH) in Melbourne.

“We’re delighted to achieve this regulatory milestone ahead of schedule and continue to expand PainChek’s global markets,” PainChek CEO Philip Daffas said. “The PainChek Infant App is unique in that it completes a microfacial analysis through a three-second video assessment and provides the carer with an instant result in relation to the infant’s pain-severity level.

“PainChek assesses and documents pain scores for adults who cannot verbalise, adults who can self-report and now infants. PainChek is rapidly becoming a universal pain assessment system for all people, everywhere.

“Having established the initial PainChek Adult App and the business model in aged care, this broad portfolio of offerings provides the foundation for our global market entry into the larger home care and the hospital markets. It’s a truly exciting time for the company,” Daffas added.

Existing clinical paper-based tools to assess pain for pre-verbal children, such as the FLACC, have been available for some time; however, they are rarely used in clinical practice, with clinicians and nurses often relying on clinical observations to assess pain, of which the infant’s facial expressions are the most critical. High levels of exposure to painful face expressions can lead to observer bias, with some healthcare professionals showing an exaggerated underestimation of pain. PainChek Infant’s automated facial analysis addresses this problem.