Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials

Area of Science:

• Neonatal pain research
• Clinical trial design
• Neuroscience

Background:

• Hospitalized neonates experience significant pain, yet effective analgesics are limited.
• Ethical and experimental challenges complicate pain management research in infants.
• Electroencephalography (EEG)-derived measures of brain activity are used to assess pain relief, but require large sample sizes due to response variability.

Purpose of the Study:

• To develop an experimental paradigm to account for individual differences in pain sensitivity in neonates.
• To improve the efficiency and reduce sample sizes in neonatal analgesic trials.
• To provide a foundation for safe and cost-effective clinical trials of pain relief in newborns.

Main Methods:

• Developed and tested a novel experimental paradigm using clinical, experimental, and simulated data.
• Utilized electroencephalography (EEG)-derived measures of noxious-evoked brain activity.
• Included data from 92 neonates across four observational studies.

Main Results:

• The paradigm effectively accounts for individual differences in baseline pain sensitivity.
• Demonstrated evidence for the efficacy of gentle brushing as a non-pharmacological intervention.
• Provided evidence supporting the efficacy of paracetamol for neonatal pain relief.

Conclusions:

• The developed paradigm can optimize the design of neonatal analgesic trials.
• Gentle brushing and paracetamol show promise as effective pain interventions in neonates.
• This research is a crucial step towards more efficient and ethical clinical trials for infant pain management.