Effectiveness of ketorolac tromethamine in prevention of severe retinopathy of prematurity.
OBJECTIVE
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.


CONCLUSIONS
This report suggests that ketorolac tromethamine ophthalmic solution cannot reduce the risk of developing severe ROP in preterm infants.
Giannantonio
Carmen
C
Department of Pediatrics, Catholic University Sacred Heart, 00168 Rome, Italy. carmengiannantonio@libero.it
Papacci
Patrizia
P
Purcaro
Velia
V
Cota
Francesco
F
Tesfagabir
Mikael Ghennet
MG
Molle
Fernando
F
Lepore
Domenico
D
Baldascino
Antonio
A
Romagnoli
Costantino
C
D001724:Birth Weight; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D020911:Ketorolac Tromethamine; D012178:Retinopathy of Prematurity / Q000175:diagnosis; D012307:Risk Factors
D020911:Ketorolac Tromethamine