Paracetamol vs Ibuprofen in Hemodynamically Significant Patent Ductus Arteriosus (HsPDA) in Preterms: A Randomized Controlled Trial
Abstract
Background and Objective: Hemodynamically significant patent ductus arteriosus (HsPDA) is a common cause of morbidity in preterm infants. Indomethacin and Ibuprofen, which are cyclooxygenase (COX) 1, 2 inhibitors are commonly used drugs for closure of HsPDA. As, Ibuprofen has several contraindications, we designed study using oral paracetamol (a peroxidase inhibitor) and compared with oral ibuprofen, for efficacy and safety in relation to closure of HsPDA in preterm infants. Methods: 140 preterm infants (gestational age less than 32 weeks) with HsPDA (confirmed by 2D Echo) were randomly assigned in two groups and received first course of either oral paracetamol (70) or ibuprofen (70). The need for a second course was determined by 2D Echo evaluation. Parameters studied were rate of ductal closure, any adverse effects and discharge rate. Results: Both groups were similar in term of ductal closure after first course (p=0.46) and second course (p=0.59). However, 22 from Ibuprofen group and only 2 from PCM group developed Original Research Article Sinol et al.; AJPR, 3(1): 6-13, 2020; Article no.AJPR.53392 7 adverse effects (p<0.001). From paracetamol group 58 were discharged, and 12 died; while from ibuprofen group 46 discharged, 24 died (p=0.03). Conclusion: Paracetamol for HsPDA in preterm neonates was associated with good efficacy and better safety; and less deaths, as compared to ibuprofen.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 140 participants or records.
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