Cargando…
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...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
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 |
_version_ | 1783686662625165312 |
---|---|
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. |
format | Online Article Text |
id | pubmed-8087440 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | eLife Sciences Publications, Ltd |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT cobomariam quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT hartleycaroline quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT gursuldeniz quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT andritsoufoteini quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT vandervaartmarianne quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT schmidtmelladogabriela quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT baxterluke quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT duffeugenep quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT bucklemiranda quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT evansfryria quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT greengabrielle quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT hoskinamy quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT rogersrichard quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT adamseleri quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT moultriefiona quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials AT slaterrebeccah quantifyingnoxiousevokedbaselinesensitivityinneonatestooptimiseanalgesictrials |