Abstract
Background Although indomethacin (IND) is the standard treatment for hemodynamically significant
patent ductus arteriosus (hsPDA) in Japan, it may be associated with renal impairment
and gastrointestinal complications. The use of paracetamol for hsPDA closure has recently
increased. Unlike IND, paracetamol does not have a peripheral vasoconstrictive effect
and can be given to infants with contraindications to IND. Based on limited data available
from randomized trials, paracetamol and IND seem to have similar effects. However,
there have been no reports of the use of paracetamol for hsPDA in Japan.
Cases Our drug administration protocol was approved by the institutional ethics committee
after purchasing a clinical trial insurance. In three premature infants in whom IND
was contraindicated or ineffective, a 7.5 mg/kg of paracetamol was intravenously administered
every 6 hour for 3 days after obtaining parental consents. A temporary hsPDA closure
was observed in two of the three infants. However, all three infants eventually needed
surgical closure. No side effects, such as hepatic and renal dysfunctions, and adverse
events were reported.
Conclusion The intravenous administration of paracetamol was safe and feasible in premature
infants with hsPDA. Future clinical trials with optimized dose and timing of administration
are needed.
Keywords
indomethacin - paracetamol - patent ductus arteriosus - premature infant - surgical
closure
