J Med Assoc Thai 2002; 85 (11):1252

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Oral Ibuprofen and Indomethacin for Treatment of Patent Ductus Arteriosus in Premature Infants : A Randomized Trial at Ramathibodi Hospital
Supapannachart S Mail, Limrungsikul A , Khowsathit P

Background : Ibuprofen given intravenously to premature newborn infants is a proven treatment
for patent ductus arteriosus (PDA). The efficacy of ibuprofen is comparable to indomethacin
in many clinical trials with fewer renal side effects. However, the intravenous form of ibuprofen is
not available in Thailand, whereas, the oral suspension form is widely used for antipyretic treatment
in children. Therefore, the authors investigated the possibilities of using oral ibuprofen for the treatment
of PDA in premature newborn infants.
Objective : To assess whether oral ibuprofen at 10 mg/kg/dose daily for 3 days was as
effective as indomethacin to treat symptomatic PDA in premature infants and to compare the side
effects of oral ibuprofen to indomethacin.
Subjects and Method : Eighteen premature infants with gestational ages less than 34 weeks
born at Ramathibodi Hospital who developed symptomatic PDA were randomly assigned to receive
three doses of either indomethacin (oral or intravenous administration 0.2 mglkg/dose for three doses
given at 12 hourly intervals or oral ibuprofen (10 mg/kg/dose for three doses given at 24 hourly
intervals). The rates of ductal closure, infants' clinical courses, side effects and complications were
recorded.
Results : Birth weight, gestational age, gender, age onset and number of infants who had
respiratory distress syndrome were similar in both groups, PDA was closed in 7 of 9 infants given
ibuprofen (78%) and in 8 of 9 infants given indomethacin (89%) (p>0.05). The mean plasma concentration
of ibuprofen was 28.05 µg/ml at 1 hour after the third dose. Neonates in the ibuprofen group
had more urine output. However, the increment of serum BUN and creatinine were not significantly
different in both groups. There were no significant differences in duration of ventilator support as well
as number of patients with bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing
enterocolitis and death in both groups.
Conclusion : Oral ibuprofen therapy is as effective as indomethacin for the treatment of
PDA in premature infants and seems to have fewer renal side effects.
Key word : Ibuprofen, Indomethacin, Patent Ductus Arteriosus, Premature

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