Treatment of retinopathy of prematurity with topical ketorolac tromethamine: a preliminary study.
BACKGROUND
Retinopathy of Prematurity (ROP) is a common retinal neovascular disorder of premature infants. It is of variable severity, usually heals with mild or no sequelae, but may progress to blindness from retinal detachments or severe retinal scar formation. This is a preliminary report of the effectiveness and safety of a new and original use of topical ketorolac in preterm newborn to prevent the progression of ROP to the more severe forms of this disease.


METHODS
From January 2001 to December 2002, all fifty nine preterm newborns with birthweight less than 1250 grams or gestational age less than 30 weeks of gestational age admitted to neonatal intensive care were eligible for treatment with topical ketorolac (0.25 milligrams every 8 hours in each eye). The historical comparison group included all 53 preterm newborns, with the same inclusion criteria, admitted between January 1999 and December 2000.


RESULTS
Groups were comparable in terms of weight distribution, Apgar score at 5 minutes, incidence of sepsis, intraventricular hemorrhage and necrotizing enterocolitis. The duration of oxygen therapy was significantly longer in the control group. In the ketorolac group, among 43 children that were alive at discharge, one (2.3%) developed threshold ROP and cryotherapy was necessary. In the comparison group 35 children survived, and six child (17%) needed cryotherapy (Relative Risk 0.14, 95%CI 0.00 to 0.80, p = 0.041). Adjusting by duration of oxygen therapy did not significantly change these results. Adverse effects attributable to ketorolac were not detected.


CONCLUSIONS
This preliminary report suggests that ketorolac in the form of an ophthalmic solution can reduce the risk of developing severe ROP in very preterm newborns, without producing significant adverse side effects. These results, although promising, should be interpreted with caution because of the weakness of the study design. This is an inexpensive and simple intervention that might ameliorate the progression of a disease with devastating consequences for children and their families. We believe that next logical step would be to assess the effectiveness of this intervention in a randomized controlled trial of adequate sample size.
NICU, Neonatalogy Service, Hospital Universitario de Maternidad y Neonatologia, Universidad Nacional de Córdoba, Córdoba, Argentina. medarav@mater.fcm.unc.edu.ar
Medardo
M
Avila-Vazquez
Roque
R
Maffrand
Mirta
M
Sosa
Maria
M
Franco
Beatriz Vaca
BV
De Alvarez
Maria Luisa
ML
Cafferata
Eduardo
E
Bergel
D000287:Administration, Topical; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D001118:Argentina / Q000453:epidemiology; D015331:Cohort Studies; D015897:Comorbidity; D018450:Disease Progression; D005260:Female; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007234:Infant, Premature; D020911:Ketorolac Tromethamine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009883:Ophthalmic Solutions; D010102:Oxygen Inhalation Therapy / Q000706:statistics & numerical data; D012178:Retinopathy of Prematurity / Q000188:drug therapy* / Q000453:epidemiology / Q000517:prevention & control; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D020911:Ketorolac Tromethamine