Safety and Efficacy of Oral Paracetamol Versus Oral Ibuprofen in Closure of Pda Among Premature Neonates Admitted to Neonatal Care Unit in Al-Ramadi Teaching Hospital for Maternity and Childhood

Abstract

Patent ductus arteriosus (PDA) is one of the most common congenital heart defects in preterm neonates. In the last years, paracetamol has been proposed for the treatment of PDA. The aim of this study was to evaluate the efficacy and safety of oral paracetamol in the closure of the Patent Ductus Arteriosus in preterm infants and to compare it with oral ibuprofen. A randomized controlled trial study was conducted in the neonatal care unit (NCU) at Al-Ramadi Teaching Hospital for Maternity and Childhood with 46 preterm children, divided into two groups. The first included 23 children treated with oral ibuprofen. The second included 23 children treated with oral paracetamol, were randomly assigned to receive either oral paracetamol or ibuprofen. After the initial treatment course in both groups, the need for a second course was determined by echocardiographic evaluation This study was extended throughout 2021 from 1st of January to 1st of July. Paracetamol after 1st course of treatment was able to achieve a success rate of (17 cases 73.9%) against the success rate of ibuprofen treatment, which reached (18 cases 78.3%), but without significant difference between the two treatments P = 0.823. this result demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen. In fact, the incidence of gastrointestinal bleeding in the paracetamol group (0 case 0%) was significantly lower than that of the ibuprofen group (4 cases 17.4%) with significant association found between both groups (P= 0.045) .This comparison of drug efficacy and safety profiles in premature infants with PDA revealed that oral paracetamol was comparable to ibuprofen in terms of the rate of ductal closure and even showed a decreased risk of gastrointestinal bleeding. Therefore, paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants