{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T11:40:05Z","timestamp":1787312405153,"version":"build-2736575974"},"reference-count":33,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,3,4]],"date-time":"2025-03-04T00:00:00Z","timestamp":1741046400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009647","name":"Ministry of Health","doi-asserted-by":"publisher","award":["5M\u20102018\u201023680408"],"award-info":[{"award-number":["5M\u20102018\u201023680408"]}],"id":[{"id":"10.13039\/100009647","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Anesthesia"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patients undergoing Pectus Excavatum repair with the minimally invasive approach frequently report severe postoperative pain. The goal of the study is to determine the superiority of cryoanalgesia compared to standard of care for return to normal quality of life.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized, active controlled, parallel groups trial (category IIb medical device) was designed for patients undergoing pectus excavatum repair. Participants were screened from the elective surgical lists at Istituto Gaslini, Genova, Italy, and they all were part of the academic practice setting. Once enrolled, patients were randomly assigned to one of the two study arms: cryoanalgesia vs. standard of care (epidural\u2010based analgesia). The primary outcome was the Pediatric Quality of Life (PedsQL) and the subcomponents (psychosocial and physical health) 14\u2009days after surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Protocol was approved by the Ethics Committee (278\/2021\u2014DB id 11\u2009421) and conducted between February 2022 and October 2023. Eighty\u2010eight patients were enrolled in the study: forty\u2010five to cryoanalgesia and forty\u2010three in the epidural arm. The PedsQL median (IQR) at the 14th day was 59.8 (48.4, 71.2) vs. 67.9 (58.7, 73.9) (95% CI: 0.46\u201313; difference 6.5;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.07) with ITT analysis, and 59.8 (48.37, 71.20) vs. 69.02 (58.70, 73.91) (95% CI: 0.82, 14; difference 7.4;\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.028) with PP analysis, in the cryoanalgesia and in the standard of care group, respectively. Irrespective of treatment, a significant decrease in both the PedsQL total score and its subcomponents was found. This effect persisted when stratified by treatment: physical health showed a decrease in both arms, while psychosocial health demonstrated a more marked decrease in the standard of care arm (\n                      <jats:italic>q<\/jats:italic>\n                      \u2010value\u2009=\u20090.028), but not in the cryoanalgesia arm (\n                      <jats:italic>q<\/jats:italic>\n                      \u2010value\u2009=\u20090.056).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Cryoanalgesia did not improve return to baseline quality of life 2\u2009weeks after surgery. However, it showed to be beneficial in the psychosocial component of the PedsQL scale.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      NCT05201820\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pan.15090","type":"journal-article","created":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T17:09:49Z","timestamp":1741712989000},"page":"347-358","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial"],"prefix":"10.1111","volume":"35","author":[{"given":"M.","family":"Bastianello","sequence":"first","affiliation":[{"name":"Unit for Research in Anaesthesia IRCCS Istituto Giannina Gaslini  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Torre","sequence":"additional","affiliation":[{"name":"Paediatric Thoracic and Airway Surgery Unit IRCCS Istituto Giannina Gaslini  Genova Italy"},{"name":"Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health University of Genova  Genoa Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"Bonfiglio","sequence":"additional","affiliation":[{"name":"Unit for Research in Anaesthesia IRCCS Istituto Giannina Gaslini  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. G.","family":"Calevo","sequence":"additional","affiliation":[{"name":"Biostatistics Unit IRCCS Istituto Giannina Gaslini  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Palomba","sequence":"additional","affiliation":[{"name":"Health Professionals Direction, IRCCS Istituto Giannina Gaslini  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Uva","sequence":"additional","affiliation":[{"name":"Clinical Bioinformatics IRCCS Istituto Giannina Gaslini  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Kanapari","sequence":"additional","affiliation":[{"name":"Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, and Vascular Sciences and Public Health University of Padova  Padova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Lorenzoni","sequence":"additional","affiliation":[{"name":"Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, and Vascular Sciences and Public Health University of Padova  Padova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2960-9333","authenticated-orcid":false,"given":"N.","family":"Disma","sequence":"additional","affiliation":[{"name":"Unit for Research in Anaesthesia IRCCS Istituto Giannina Gaslini  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"COPPER 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