{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T07:02:29Z","timestamp":1781766149838,"version":"3.54.5"},"reference-count":138,"publisher":"Public Library of Science (PLoS)","issue":"12","license":[{"start":{"date-parts":[[2023,12,7]],"date-time":"2023-12-07T00:00:00Z","timestamp":1701907200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Background<\/jats:title>\n<jats:p>Therapeutic hypothermia (TH) is a widely practiced neuroprotective strategy for neonates with hypoxic-ischemic encephalopathy. Induced hypothermia is associated with shivering, cold pain, agitation, and distress.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Objective<\/jats:title>\n<jats:p>This scoping review determines the breadth of research undertaken for pain and stress management in neonates undergoing hypothermia therapy, the pharmacokinetics of analgesic and sedative medications during hypothermia and the effect of such medication on short- and long-term neurological outcomes.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Methods<\/jats:title>\n<jats:p>We searched the following online databases namely, (i) MEDLINE, (ii) Web of Science, (iii) Cochrane Library, (iv) Scopus, (v) CINAHL, and (vi) EMBASE to identify published original articles between January 2005 and December 2022. We included only English full-text articles on neonates treated with TH and reported the sedation\/analgesia strategy used. We excluded articles that reported TH on transport or extracorporeal membrane oxygenation, did not report the intervention strategies for sedation\/analgesia, and reported hypoxic-ischemic encephalopathy in which hypothermia was not applied.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Results<\/jats:title>\n<jats:p>The eligible publications (n = 97) included cohort studies (n = 72), non-randomized experimental studies (n = 2), pharmacokinetic studies (n = 4), dose escalation feasibility trial (n = 1), cross-sectional surveys (n = 5), and randomized control trials (n = 13). Neonatal Pain, Agitation, and Sedation Scale (NPASS) is the most frequently used pain assessment tool in this cohort. The most frequently used pharmacological agents are opioids (Morphine, Fentanyl), benzodiazepine (Midazolam) and Alpha2 agonists (Dexmedetomidine). The proportion of neonates receiving routine sedation-analgesia during TH is center-specific and varies from 40\u2013100% worldwide. TH alters most drugs\u2019 metabolic rate and clearance, except for Midazolam. Dexmedetomidine has additional benefits of thermal tolerance, neuroprotection, faster recovery, and less likelihood of seizures. There is a wide inter-individual variability in serum drug levels due to the impact of temperature, end-organ dysfunction, postnatal age, and body weight on drug metabolism.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec005\">\n<jats:title>Conclusions<\/jats:title>\n<jats:p>No multidimensional pain scale has been tested for reliability and construct validity in hypothermic encephalopathic neonates. There is an increasing trend towards using routine sedation\/analgesia during TH worldwide. Wide variability in the type of medication used, administration (bolus versus infusion), and dose ranges used emphasizes the urgent need for standardized practice recommendations and guidelines. There is insufficient data on the long-term neurological outcomes of exposure to these medications, adjusted for underlying brain injury and severity of encephalopathy. Future studies will need to develop framework tools to enable precise control of sedation\/analgesia drug exposure customized to individual patient needs.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0291170","type":"journal-article","created":{"date-parts":[[2023,12,7]],"date-time":"2023-12-07T18:26:03Z","timestamp":1701973563000},"page":"e0291170","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":18,"title":["Analgesia and sedation strategies in neonates undergoing whole-body therapeutic hypothermia: A scoping review"],"prefix":"10.1371","volume":"18","author":[{"given":"Mahima","family":"Joshi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6202-8725","authenticated-orcid":true,"given":"Javed","family":"Muneer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Mbuagbaw","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4677-6456","authenticated-orcid":true,"given":"Ipsita","family":"Goswami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,12,7]]},"reference":[{"issue":"1","key":"pone.0291170.ref001","first-page":"50","article-title":"Intrapartum-related neonatal encephalopathy incidence and impairment at regional and global levels for 2010 with trends from 1990","volume":"74","author":"ACC Lee","year":"2013","journal-title":"Pediatric Research"},{"issue":"1","key":"pone.0291170.ref002","article-title":"Cooling for newborns with hypoxic ischaemic encephalopathy","author":"SE Jacobs","year":"2013","journal-title":"Cochrane Database of Systematic Reviews"},{"issue":"6","key":"pone.0291170.ref003","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1016\/j.pedneo.2016.11.001","article-title":"Therapeutic hypothermia for neonates with hypoxic ischemic encephalopathy","volume":"58","author":"MC Chiang","year":"2017","journal-title":"Pediatr Neonatol"},{"issue":"6","key":"pone.0291170.ref004","doi-asserted-by":"crossref","first-page":"608","DOI":"10.1007\/s11940-012-0200-y","article-title":"Therapeutic hypothermia for neonatal encephalopathy","volume":"14","author":"S. Shankaran","year":"2012","journal-title":"Curr Treat Options Neurol"},{"issue":"1","key":"pone.0291170.ref005","doi-asserted-by":"crossref","first-page":"2","DOI":"10.1007\/s11910-019-0916-0","article-title":"Therapeutic Hypothermia in Neonatal Hypoxic-Ischemic Encephalopathy","volume":"19","author":"G Wassink","year":"2019","journal-title":"Current Neurology and Neuroscience Reports"},{"issue":"3","key":"pone.0291170.ref006","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1152\/advan.00126.2014","article-title":"Recent advances in thermoregulation","volume":"39","author":"EA Tansey","year":"2015","journal-title":"Advances in Physiology Education"},{"issue":"2","key":"pone.0291170.ref007","doi-asserted-by":"crossref","first-page":"87","DOI":"10.1016\/j.siny.2014.10.005","article-title":"Physiological responses to hypothermia","volume":"20","author":"T Wood","year":"2015","journal-title":"Semin Fetal Neonatal Med"},{"key":"pone.0291170.ref008","first-page":"1","article-title":"Thermogenesis in human brown adipose tissue and skeletal muscle induced by sympathomimetic stimulation","volume":"278","author":"A. 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Odd","year":"2021","journal-title":"BMJ Paediatrics Open"},{"issue":"25","key":"pone.0291170.ref033","doi-asserted-by":"crossref","first-page":"7764","DOI":"10.1080\/14767058.2021.1937106","article-title":"Fentanyl analgesia in asphyxiated newborns treated with therapeutic hypothermia","volume":"35","author":"L Lugli","year":"2022","journal-title":"The journal of maternal-fetal & neonatal medicine: the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians"},{"issue":"3","key":"pone.0291170.ref034","doi-asserted-by":"crossref","first-page":"628","DOI":"10.1111\/apa.15071","article-title":"Pain management during therapeutic hypothermia in newborn infants with hypoxic-ischaemic encephalopathy","volume":"109","author":"P Lago","year":"2020","journal-title":"Acta paediatrica (Oslo, Norway: 1992)"},{"key":"pone.0291170.ref035","author":"L Fredriksson","year":"2013","journal-title":"Assessment and management of pain inneonates treated with mild hypothermiafollowing neonatal asphyxia"},{"issue":"2","key":"pone.0291170.ref036","doi-asserted-by":"crossref","first-page":"150","DOI":"10.1159\/000368180","article-title":"Anticonvulsant effectiveness and hemodynamic safety of midazolam in full-term infants treated with hypothermia","volume":"107","author":"MPH van den Broek","year":"2015","journal-title":"Neonatology"},{"issue":"7","key":"pone.0291170.ref037","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1055\/s-0033-1358749","article-title":"Disposition of midazolam in asphyxiated neonates receiving therapeutic hypothermia\u2014a pilot study","volume":"225","author":"L Welzing","year":"2013","journal-title":"Klinische Padiatr"},{"key":"pone.0291170.ref038","article-title":"Morphine and fentanyl exposure during therapeutic hypothermia does not impair neurodevelopment","volume":"36","author":"((Gundersen, Menassa, Walloe, Thoresen)","year":"2021","journal-title":"EClinicalMedicine"},{"issue":"5","key":"pone.0291170.ref039","doi-asserted-by":"crossref","first-page":"809","DOI":"10.1542\/peds.2013-0787","article-title":"Xenon ventilation during therapeutic hypothermia in neonatal encephalopathy: a feasibility study","volume":"133","author":"J Dingley","year":"2014","journal-title":"Pediatrics"},{"issue":"4","key":"pone.0291170.ref040","doi-asserted-by":"crossref","first-page":"405","DOI":"10.1136\/archdischild-2019-317311","article-title":"Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): A randomised controlled trial","volume":"105","author":"K Aker","year":"2020","journal-title":"Archives of Disease in Childhood: Fetal and Neonatal Edition"},{"issue":"101159952","key":"pone.0291170.ref041","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1186\/1476-7120-11-34","article-title":"Speckle tracking derived strain in infants with severe perinatal 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Liu","year":"2021","journal-title":"Frontiers in Neurology"},{"issue":"2","key":"pone.0291170.ref059","doi-asserted-by":"crossref","first-page":"195","DOI":"10.1055\/s-0035-1563712","article-title":"Newborns Referred for Therapeutic Hypothermia: Association between Initial Degree of Encephalopathy and Severity of Brain Injury (What about the Newborns with Mild Encephalopathy on Admission?)","volume":"33","author":"M Gagne-Loranger","year":"2015","journal-title":"American Journal of Perinatology"},{"key":"pone.0291170.ref060","doi-asserted-by":"crossref","first-page":"52","DOI":"10.1016\/j.pediatrneurol.2022.06.006","article-title":"Association Between Early EEG Background and Outcomes in Infants With Mild HIE Undergoing Therapeutic Hypothermia","volume":"134","author":"N Natarajan","year":"2022","journal-title":"PEDIATRIC NEUROLOGY"},{"issue":"6","key":"pone.0291170.ref061","doi-asserted-by":"crossref","first-page":"1075","DOI":"10.1177\/0271678X15607881","article-title":"The effects 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