{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T23:49:45Z","timestamp":1772840985920,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.10005.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2017,1,26]],"date-time":"2017-01-26T00:00:00Z","timestamp":1485388800000}}],"reference-count":47,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2017,1,26]],"date-time":"2017-01-26T00:00:00Z","timestamp":1485388800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Wellcome Trust","award":["095802"],"award-info":[{"award-number":["095802"]}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns4:p>Infant pain has both immediate and long-term negative consequences, yet in clinical practice it is often undertreated. To date, few pain-relieving drugs have been tested in infants. Morphine is a potent analgesic that provides effective pain relief in adults, but there is inconclusive evidence for its effectiveness in infants. The purpose of this study is to establish whether oral morphine provides effective analgesia for procedural pain in infants.<\/ns4:p>\n                  <ns4:p>A blinded, placebo-controlled, parallel-group randomized, phase II, clinical trial will be undertaken to determine whether morphine sulphate administered orally prior to clinically-required retinopathy of prematurity (ROP) screening and heel lancing provides effective analgesia. \u2028156 infants between 34 and 42 weeks\u2019 gestational age who require a clinical heel lance and ROP screening on the same test occasion will be included in the trial. Infants will be randomised to receive either a single dose of morphine sulphate (100 \u03bcg\/kg) or placebo. Each infant will be monitored for 48 hours and safety data will be collected during the 24 hours following drug administration.<\/ns4:p>\n                  <ns4:p>\n                    The primary outcome will be the Premature Infant Pain Profile\u2013revised (PIPP-R) score during the 30 second periods after ROP screening. The co-primary outcome will be the magnitude of nociceptive-specific brain activity evoked by a clinically-required heel lance. Infant clinical stability will be assessed by comparing the number of episodes of bradycardia, tachycardia, desaturation and apnoea, and changes in respiratory support requirements in the 24-hour periods before and after the clinical intervention. In addition, drug safety will be assessed by considering the occurrence of apnoeic and hypotensive episodes requiring intervention in the 24-hour period following drug administration. This study has been published as an\n                    <ns4:italic>Accepted Protocol Summary<\/ns4:italic>\n                    by\n                    <ns4:italic>The Lancet<\/ns4:italic>\n                    .\n                  <\/ns4:p>","DOI":"10.12688\/wellcomeopenres.10005.2","type":"journal-article","created":{"date-parts":[[2017,1,26]],"date-time":"2017-01-26T07:10:05Z","timestamp":1485414605000},"page":"7","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":4,"title":["A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants: Trial protocol"],"prefix":"10.12688","volume":"1","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1595-4846","authenticated-orcid":false,"given":"Rebeccah","family":"Slater","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Caroline","family":"Hartley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fiona","family":"Moultrie","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eleri","family":"Adams","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ed","family":"Juszczak","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Rogers","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6031-6953","authenticated-orcid":false,"given":"Jane E.","family":"Norman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chetan","family":"Patel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kayleigh","family":"Stanbury","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Hoskin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabrielle","family":"Green","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"Poppi Trial Team","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2017,1,26]]},"reference":[{"key":"ref-1","article-title":"Protocol 15PRT\/5747: A blinded randomised placebo-controlled trial investigating the efficacy of morphine analgesia for procedural pain in infants.","author":"C Hartley","year":"2016","journal-title":"Lancet."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"189-90","DOI":"10.1016\/S0140-6736(08)61053-3","article-title":"Protocol review at The Lancet.","volume":"372","author":"D McNameea","year":"2008","journal-title":"Lancet."},{"key":"ref-3","doi-asserted-by":"publisher","first-page":"2456-2457","DOI":"10.1016\/S0140-6736(15)01131-9","article-title":"Protocol review at The Lancet: 1997\u2013 2015.","volume":"386","year":"2015","journal-title":"Lancet."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"60-70","DOI":"10.1001\/jama.300.1.60","article-title":"Epidemiology and treatment of painful procedures in neonates in intensive care units.","volume":"300","author":"R Carbajal","year":"2008","journal-title":"JAMA."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"107-11","DOI":"10.1038\/sj.jp.7211822","article-title":"Procedural pain guidelines for the newborn in the United Kingdom.","volume":"28","author":"L McKechnie","year":"2008","journal-title":"J Perinatol."},{"key":"ref-6","doi-asserted-by":"publisher","first-page":"338-50","DOI":"10.1016\/j.jpain.2012.12.017","article-title":"The infancy of infant pain research: the experimental origins of infant pain denial.","volume":"14","author":"E Rodkey","year":"2013","journal-title":"J Pain."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"F38-41","DOI":"10.1136\/fn.82.1.F38","article-title":"Premedication before intubation in UK neonatal units.","volume":"82","author":"S Whyte","year":"2000","journal-title":"Arch Dis Child Fetal Neonatal Ed."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"286-9","DOI":"10.1038\/sj.jp.7211499","article-title":"Are newborns receiving premedication before elective intubation?","volume":"26","author":"S Sarkar","year":"2006","journal-title":"J Perinatol."},{"key":"ref-9","article-title":"Special care for sick babies - choice or chance? 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Hospital, Rotterdam, 3015 CN, The Netherlands, 31 Jan 2017, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/1-7\/v2#referee-response-19772","order":2,"name":"referee-response-19772","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by the Wellcome Trust [095802]; National Institute of Health Research Funding [14\/187\/01]. This project is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership.\u00a0. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}