Comparison of Oral Paracetamol versus Ibuprofen in Premature Infants with Patent Ductus Arteriosus: A Randomized Controlled Trial
Open Access
- 4 November 2013
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 8 (11), e77888
- https://doi.org/10.1371/journal.pone.0077888
Abstract
Oral ibuprofen has demonstrated good effects on symptomatic patent ductus arteriosus (PDA) but with many contraindications and potential side-effects. In the past two years, oral paracetamol administration to several preterm infants with PDA has been reported. Here, a randomized, non-blinded, parallel-controlled and non-inferiority trial was designed to evaluate the efficacy and safety profiles of oral paracetamol to those of standard ibuprofen for PDA closure in premature infants. One hundred and sixty infants (gestational age ≤34 weeks) with echocardiographically confirmed PDA were randomly assigned to receive either oral paracetamol (n = 80) or ibuprofen (n = 80). After the initial treatment course in both groups, the need for a second course was determined by echocardiographic evaluation. The main outcome was rate of ductal closure, and secondary outcomes were adverse effects and complications. The ductus was closed in 65 (81.2%) infants of the paracetamol group compared with 63 (78.8%) of the ibuprofen group. The 95% confidence interval of the difference between these groups was [−0.080,0.128], demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen. In fact, the incidence of hyperbilirubinemia or gastrointestinal bleeding in the paracetamol group was significantly lower than that of the ibuprofen group. No significant differences in other clinical side effects or complications were noted. 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 hyperbilirubinemia or gastrointestinal bleeding. Therefore, paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants. ChiCTR.org ChiCTR-TRC-12002177This publication has 33 references indexed in Scilit:
- Intravenous Paracetamol Treatment in the Management of Patent Ductus Arteriosus in Extremely Low Birth Weight InfantsNeonatology, 2012
- An alternative drug (paracetamol) in the management of patent ductus arteriosus in ibuprofen-resistant or contraindicated preterm infantsArchives of Disease in Childhood: Fetal & Neonatal, 2012
- Failure of a repeat course of cyclooxygenase inhibitor to close a PDA is a risk factor for developing chronic lung disease in ELBW infantsBMC Pediatrics, 2012
- Ductal Closure With Paracetamol: A Surprising New Approach to Patent Ductus Arteriosus TreatmentPEDIATRICS, 2011
- Comparison of renal effects of ibuprofen versus indomethacin during treatment of patent ductus arteriosus in contiguous historical cohortsBMC Clinical Pharmacology, 2011
- Relationship between Circulating Platelet Counts and Ductus Arteriosus Patency after Indomethacin TreatmentThe Journal of Pediatrics, 2011
- Efficacy and Safety of Oral Versus Intravenous Ibuprofen in Very Low Birth Weight Preterm Infants with Patent Ductus ArteriosusThe Journal of Pediatrics, 2011
- Pharmacology ReviewNeoReviews, 2005
- Effect of ibuprofen on bilirubin-albumin bindingThe Journal of Pediatrics, 2004
- Does Ibuprofen Affect Bilirubin‐Albumin Binding in Newborn Infant Serum?Basic & Clinical Pharmacology & Toxicology, 1996