{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T13:26:23Z","timestamp":1783776383730,"version":"3.55.0"},"reference-count":25,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2021,9,16]],"date-time":"2021-09-16T00:00:00Z","timestamp":1631750400000},"content-version":"unspecified","delay-in-days":15,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,7,28]]},"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To investigate if intravenous fentanyl or intravenous ketamine can provide adequate analgesia in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Open-label randomised trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Tertiary care institution.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Preterm infants who underwent laser photocoagulation for ROP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Infants were randomised to receive fentanyl as intravenous bolus dose of 2\u2009\u00b5g\/kg, followed by an intravenous infusion of 1\u2009\u00b5g\/kg\/hour increased to a maximum of 3\u2009\u00b5g\/kg\/hour or intravenous ketamine as bolus dose of 0.5\u2009mg\/kg, followed by further intermittent intravenous bolus doses of 0.5\u2009mg\/kg to a maximum of 2\u2009mg\/kg in the initial phase and intravenous fentanyl (bolus of 2\u2009\u00b5g\/kg followed by infusion of 2\u2009\u00b5g\/kg\/hour to a maximum of 5\u2009\u00b5g\/kg\/hour) or intravenous ketamine (bolus dose of 1\u2009mg\/kg followed by intermittent bolus doses of 0.5\u2009mg\/kg to a maximum of 4\u2009mg\/kg) in the revised regimen phase.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>Proportion of infants with adequate analgesia defined as the presence of both: (1) all the Premature Infant Pain Profile-Revised scores measured every 15\u2009min less than seven and (2) proportion of the procedure time the infant spent crying less than 5%.<\/jats:p>\n                    <jats:p>Secondary outcomes included apnoea, cardiorespiratory or haemodynamic instability, feed intolerance and urinary retention requiring catheterisation during and within 24 hours following the procedure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 97 infants were randomised (fentanyl=51, ketamine=46). The proportions of infants with adequate analgesia were 16.3% (95% CI 8.5% to 29%) with fentanyl and 4.5% (95% CI 1.3% to 15.1%) with ketamine. Ten infants (19.6%) in the fentanyl group and seven infants (15.2%) in the ketamine group had one or more side effects. In view of inadequate analgesia with both the regimens, the study steering committee recommended using a higher dose of intravenous fentanyl and intravenous ketamine. Consequently, we enrolled 27 infants (fentanyl=13, ketamine=14). With revised regimens, the proportions of infants with adequate analgesia were higher: 23.1% (95% CI 8.2% to 50.2%) with fentanyl and 7.1% (95% CI 1.3% to 31.5%) with ketamine. However, higher proportions of infants developed apnoea (n=4; 30.7%), need for supplemental oxygen (n=5, 38.4%) and change in cardiorespiratory scores (n=7; 53.8%) with fentanyl but none with ketamine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Fentanyl-based and ketamine-based drug regimens provided adequate analgesia only in a minority of infants undergoing laser photocoagulation for ROP. More research is needed to find safe and effective regimens that can be employed in resource constrained settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>CTRI\/2018\/03\/012878.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-046235","type":"journal-article","created":{"date-parts":[[2021,9,16]],"date-time":"2021-09-16T12:55:29Z","timestamp":1631796929000},"page":"e046235","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["\u2018NOPAIN-ROP\u2019 trial: Intravenous fentanyl and intravenous ketamine for pain relief during laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants: A randomised trial"],"prefix":"10.1136","volume":"11","author":[{"given":"Shamnad","family":"Madathil","sequence":"first","affiliation":[{"name":"Paediatrics, All India Institute of Medical Sciences, New Delhi, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deena","family":"Thomas","sequence":"additional","affiliation":[{"name":"Paediatrics, All India Institute of Medical Sciences, New Delhi, New Delhi, India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parijat","family":"Chandra","sequence":"additional","affiliation":[{"name":"Dr R. 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