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

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 (electroencephalogr...

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Autores principales: Cobo, Maria M, Hartley, Caroline, Gursul, Deniz, Andritsou, Foteini, van der Vaart, Marianne, Schmidt Mellado, Gabriela, Baxter, Luke, Duff, Eugene P, Buckle, Miranda, Evans Fry, Ria, Green, Gabrielle, Hoskin, Amy, Rogers, Richard, Adams, Eleri, Moultrie, Fiona, Slater, Rebeccah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: eLife Sciences Publications, Ltd 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087440/
https://www.ncbi.nlm.nih.gov/pubmed/33847561
http://dx.doi.org/10.7554/eLife.65266
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author Cobo, Maria M
Hartley, Caroline
Gursul, Deniz
Andritsou, Foteini
van der Vaart, Marianne
Schmidt Mellado, Gabriela
Baxter, Luke
Duff, Eugene P
Buckle, Miranda
Evans Fry, Ria
Green, Gabrielle
Hoskin, Amy
Rogers, Richard
Adams, Eleri
Moultrie, Fiona
Slater, Rebeccah
author_facet Cobo, Maria M
Hartley, Caroline
Gursul, Deniz
Andritsou, Foteini
van der Vaart, Marianne
Schmidt Mellado, Gabriela
Baxter, Luke
Duff, Eugene P
Buckle, Miranda
Evans Fry, Ria
Green, Gabrielle
Hoskin, Amy
Rogers, Richard
Adams, Eleri
Moultrie, Fiona
Slater, Rebeccah
author_sort Cobo, Maria M
collection PubMed
description 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.
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spelling pubmed-80874402021-05-03 Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials Cobo, Maria M Hartley, Caroline Gursul, Deniz Andritsou, Foteini van der Vaart, Marianne Schmidt Mellado, Gabriela Baxter, Luke Duff, Eugene P Buckle, Miranda Evans Fry, Ria Green, Gabrielle Hoskin, Amy Rogers, Richard Adams, Eleri Moultrie, Fiona Slater, Rebeccah eLife Medicine 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. eLife Sciences Publications, Ltd 2021-04-13 /pmc/articles/PMC8087440/ /pubmed/33847561 http://dx.doi.org/10.7554/eLife.65266 Text en © 2021, Cobo et al https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use and redistribution provided that the original author and source are credited.
spellingShingle Medicine
Cobo, Maria M
Hartley, Caroline
Gursul, Deniz
Andritsou, Foteini
van der Vaart, Marianne
Schmidt Mellado, Gabriela
Baxter, Luke
Duff, Eugene P
Buckle, Miranda
Evans Fry, Ria
Green, Gabrielle
Hoskin, Amy
Rogers, Richard
Adams, Eleri
Moultrie, Fiona
Slater, Rebeccah
Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
title Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
title_full Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
title_fullStr Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
title_full_unstemmed Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
title_short Quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
title_sort quantifying noxious-evoked baseline sensitivity in neonates to optimise analgesic trials
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8087440/
https://www.ncbi.nlm.nih.gov/pubmed/33847561
http://dx.doi.org/10.7554/eLife.65266
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