![]() ![]() may enable smaller studies that can more quickly identify ways to reduce pain in babies. The new approach identified by Cobo, Hartley et al. The second showed that giving a baby the painkiller paracetamol lessened the brain’s response to immunisation. One showed that gently stroking an infant’s leg before blood is drawn from their heel reduced their brains’ response to pain. ![]() used this new approach in two pilot tests. Further data analysis revealed that this information can be used to predict the variability in pain experienced by different newborns, reducing the number of participants needed for pain relief trials. found that the babies’ response to the gentle poke correlated with their response to pain. In the experiments, the brain activity of nine babies was measured after a gentle poke and after a painful clinically required procedure. demonstrate a way to reduce the number of newborns needed to test potential pain-relieving interventions. Finding ways to reduce the size of pain control studies could lead to faster development of pain relief methods. Randomized controlled trials are the gold standard for these kinds of medical assessments, but require a high number of participants to account for individual differences in how babies respond to pain. One way to overcome this is to record the brain activity of newborns during a painful procedure and to see how these signals are modified following pain relief. However, testing the effects of pain relief in newborns is challenging because, unlike adults, they cannot report how much pain they are experiencing. This can cause the baby to experience short-term distress that may have negative consequences later in life. Hospitalized newborns often undergo medical procedures, like blood tests, without pain relief. This work provides an important step towards safe, cost-effective clinical trials of analgesics in neonates. We provide evidence of the efficacy of gentle brushing and paracetamol, substantiating the need for randomised controlled trials of these interventions. The paradigm is developed and tested across four observational studies using clinical, experimental, and simulated data (92 neonates). Here, we present an experimental paradigm to account for individual differences in noxious-evoked baseline sensitivity which can be used to improve the design of analgesic trials in neonates. EEG (electroencephalography)-derived measures of noxious-evoked brain activity can be used to assess analgesic efficacy however, as variability exists in neonate’s responses to painful procedures, large sample sizes are often required. Testing analgesics in neonates is experimentally and ethically challenging and minimising the number of neonates required to demonstrate efficacy is essential. Despite the high burden of pain experienced by hospitalised neonates, there are few analgesics with proven efficacy. ![]()
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