PURPOSE: This study assessed the effectiveness of the use of ketorolac tromethamine to reduce retinopathy of prematurity (ROP) incidence and its progression to more severe forms. METHODS:Forty-seven preterm newborn infants with a birth weight (BW) of 1,000 grams or less and/ora gestational age (GA) of 29 weeks or less were enrolled in the study when avascular retina zone I or ROP any stage were diagnosed at screening. Studied infants were randomized to receive ketorolac tromethamine ophthalmic solution in one eye and a drop of placebo in the other eye, until ROP requiring treatment or full retinal vascularization was diagnosed. RESULTS: Only 2 newborn infants did not develop ROP. Among 45 newborn infants who developed ROP, 6 showed different ROP staging between the two eyes, 4 of which had a better outcome in the eye receiving ketorolac tromethamine. The differences between ROP stagings were not significant even when analyzed by GA and BW subgroups. No significant treatment-related side effects occurred. CONCLUSION: This report suggests that ketorolac tromethamine ophthalmic solution cannot reduce the risk of developing severe ROP in preterm infants. Copyright 2011, SLACK Incorporated.
RCT Entities:
PURPOSE: This study assessed the effectiveness of the use of ketorolac tromethamine to reduce retinopathy of prematurity (ROP) incidence and its progression to more severe forms. METHODS: Forty-seven preterm newborn infants with a birth weight (BW) of 1,000 grams or less and/or a gestational age (GA) of 29 weeks or less were enrolled in the study when avascular retina zone I or ROP any stage were diagnosed at screening. Studied infants were randomized to receive ketorolac tromethamine ophthalmic solution in one eye and a drop of placebo in the other eye, until ROP requiring treatment or full retinal vascularization was diagnosed. RESULTS: Only 2 newborn infants did not develop ROP. Among 45 newborn infants who developed ROP, 6 showed different ROP staging between the two eyes, 4 of which had a better outcome in the eye receiving ketorolac tromethamine. The differences between ROP stagings were not significant even when analyzed by GA and BW subgroups. No significant treatment-related side effects occurred. CONCLUSION: This report suggests that ketorolac tromethamine ophthalmic solution cannot reduce the risk of developing severe ROP in preterm infants. Copyright 2011, SLACK Incorporated.
Authors: Kay D Beharry; Charles L Cai; Gloria B Valencia; Douglas Lazzaro; Arwin M Valencia; Fabrizio Salomone; Jacob V Aranda Journal: Prostaglandins Other Lipid Mediat Date: 2017-09-18 Impact factor: 3.072
Authors: Leeann R Pavlek; Brian K Rivera; Charles V Smith; Joanie Randle; Cory Hanlon; Kristi Small; Edward F Bell; Matthew A Rysavy; Sara Conroy; Carl H Backes Journal: J Pediatr Date: 2021-04-21 Impact factor: 6.314