TY - JOUR
T1 - Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
AU - Cobo, Maria M.
AU - Hartley, Caroline
AU - Gursul, Deniz
AU - Andritsou, Foteini
AU - van der Vaart, Marianne
AU - Mellado, Gabriela Schmidt
AU - Baxter, Luke
AU - Duff, Eugene P.
AU - Buckle, Miranda
AU - Fry, Ria Evans
AU - Green, Gabrielle
AU - Hoskin, Amy
AU - Rogers, Richard
AU - Adams, Eleri
AU - Moultrie, Fiona
AU - Slater, Rebeccah
N1 - Publisher Copyright:
© Cobo et al.
PY - 2021
Y1 - 2021
N2 - Despite the high burden of pain experienced by hospitalised neonates, there are few analgesics with proven efficacy. Testing analgesics in neonates is experimentally and ethically challenging and minimising the number of neonates required to demonstrate efficacy is essential. 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. 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. The paradigm is developed and tested across four observational studies using clinical, experimental, and simulated data (92 neonates). We provide evidence of the efficacy of gentle brushing and paracetamol, substantiating the need for randomised controlled trials of these interventions. This work provides an important step towards safe, cost-effective clinical trials of analgesics in neonates.
AB - Despite the high burden of pain experienced by hospitalised neonates, there are few analgesics with proven efficacy. Testing analgesics in neonates is experimentally and ethically challenging and minimising the number of neonates required to demonstrate efficacy is essential. 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. 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. The paradigm is developed and tested across four observational studies using clinical, experimental, and simulated data (92 neonates). We provide evidence of the efficacy of gentle brushing and paracetamol, substantiating the need for randomised controlled trials of these interventions. This work provides an important step towards safe, cost-effective clinical trials of analgesics in neonates.
UR - http://www.scopus.com/inward/record.url?scp=85105638521&partnerID=8YFLogxK
U2 - 10.7554/ELIFE.65266
DO - 10.7554/ELIFE.65266
M3 - Artículo
C2 - 33847561
AN - SCOPUS:85105638521
SN - 2050-084X
VL - 10
JO - eLife
JF - eLife
M1 - e65266
ER -