Efficacy and Safety of Paracetamol Versus Ibuprofen for Treating Patent Ductus Arteriosus in Preterm Infants: A Meta-analysis

Objectives: The objective was to review the available evidence comparing oral paracetamol versus oral ibuprofen for the closure of patent ductus arteriosus (PDA) in preterm infants. Methods: We searched all the major databases (Medline via Ovid and PubMed) till April 2014. Randomized trials were included. Primary outcome measure was the primary closure rate of PDA after the first course of the drug. Review manager (version 5.2) was used for all the analyses. GRADE criteria were used to rate the quality of evidence. Results: Of 38 full-text articles assessed for eligibility, two trials (n = 240) were included in the final analysis. There was no significant difference between the two groups except for the following parameters, which favored the paracetamol group: Shorter mean days needed for PDA closure (mean difference, -0.49 [95% confidence interval [CI], -0.54 to -0.44], P < 0.00001), a lower risk of gastro-intestinal bleeding (odds ratio [OR], 0.25 [95% CI, 0.06-1.02], P = 0.05) as well as hyperbilirubinemia (OR, 0.46 (95% CI, 0.23-0.95), P = 0.04). The GRADE evidence was found to be of "low quality." Conclusions: There is not enough evidence to judge about the efficacy or safety of ibuprofen versus paracetamol for treating the PDA in preterm infants. Randomized trials with low risk of bias and adequate sample size including different subgroups of preterm infants are needed before any firm recommendation can be made.