Background and importance Patent ductus arteriosus (PDA) is a common cause of morbidity and mortality in preterm infants. The treatment of choice is ibuprofen but contraindications and serious adverse events limits its use. Paracetamol has been proposed as an alternative to ibuprofen, with good results (80–95% efficacy) and apparently less side effects.
Aim and objectives To analyse the effectiveness and safety of intravenous paracetamol in the treatment of haemodynamically significant PDA (hsPDA).
Material and methods A retrospective cohort study of hospitalised infants was conducted in a level III neonatal intensive care unit between July 2013 and January 2019. Criteria inclusion: gestational age (GA) ≤30 weeks and treatment of hsPDA with paracetamol 15 mg/kg/6 hours (minimum 8 doses) after contraindication or ineffectiveness of ibuprofen. Closure was considered if the ductus was <1 mm and not significant. The need for post-paracetamol treatment was also analysed.
Results Fifty-four patients were included, with a median GA of 26±1.8 weeks and median birth weight of 853±293 g. In 14 patients, paracetamol was used as the first option and in 40 after ibuprofen (table 1). The overall closure rate was 37%. No adverse effects were reported during treatment.
Conclusion and relevance Our efficacy results were much lower than those published in most studies and case series. In our series, the overall efficacy of paracetamol was 37.0% and 40.5% if deceased patients were excluded from the analysis.
Well designed clinical trials are needed to help decide the role of paracetamol in the management of hsPDA as the results are very different depending on whether it is administered as the first choice (50.0% or 71.4% excluding the deceased) or after ibuprofen (32.4% or 34.3% excluding the deceased).
References and/or acknowledgements No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.