CC-BY-NC-ND 4.0 · AJP Rep 2017; 07(04): e230-e233
DOI: 10.1055/s-0037-1615260
Case Report
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Low-Dose Intravenous Paracetamol for Patent Ductus Arteriosus in Indomethacin-Resistant or Contraindicated Preterm Infants: Three Cases Reports

Shun Matsumura1, Ayumi Oshima1, Sumie Fujinuma1, Kosuke Tanaka1, Nobuhiko Nagano1, Fuyu Miyake1, Satoshi Masutani1, Masanori Tamura1, Keiko Ueda2, Fumihiko Namba1
  • 1Department of Pediatrics, Saitama Medical Center, Saitama Medical University, Kawagoe, Saitama, Japan
  • 2Clinical Research Support Center, The University of Tokyo Hospital, Bunkyo, Tokyo, Japan
Further Information

Publication History

03 August 2017

26 October 2017

Publication Date:
21 December 2017 (online)


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.