Therapeutic Efficacy and Safety of Paracetamol versus Ibuprofen in Patent Ductus Arteriosus in Newborns: A Systematic Review

ABSTRACT

Closure of the ductus arteriosus (DA) using cyclooxygenase (COX) inhibitors is considered the first-line treatment for hemodynamically significant patent ductus arteriosus (PDA). Physiologically, prostaglandins have a recognized role in PDA. Admittedly, the comparative efficacy and safety between ibuprofen and acetaminophen need to be determined for rational choice of drug therapy for closure of the DA in clinical protocols.

This study aims to present the aspects of the efficacy and therapeutic safety of paracetamol versus ibuprofen in the treatment of PDA in premature newborns.

A systematic review of the literature was carried out, following the recommendations of the PRISMA protocol, using the Medline, Pubmed, LILACS, and SciELO databases. Studies from the last 10 years (2013-2023) that analyzed the efficacy and/or safety of acetaminophen compared to ibuprofen in newborns diagnosed with PDA were included.

Eight randomized clinical trials (RCTs) were selected for analysis, resulting in a sample size of 781 newborns with PDA treated with acetaminophen or ibuprofen. The efficacy of acetaminophen for DA closure is comparable to ibuprofen. There is no statistically significant difference in the incidence of related adverse effects between the two drugs in most studies.

There is equivalence in the efficacy and safety of ibuprofen and acetaminophen to promote closure of the DA in premature newborns with hsPDA.