Paracetamol vs Ibuprofen in Hemodynamically Significant Patent Ductus Arteriosus (HsPDA) in Preterms: A Randomized Controlled Trial

Main Article Content

Hinal A Sinol
Alpa N Parekh
Jayendra R Gohil
Mehul Gosai


Background and Objective: Hemodynamically significant patent ductus arteriosus (HsPDA) is a common cause of morbidity in preterm infants. Indomethacin and Ibuprofen, which are cyclo-oxygenase (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 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.

Patent ductus arteriosus, paracetamol, ibuprofen, preterm.

Article Details

How to Cite
Sinol, H. A., Parekh, A. N., Gohil, J. R., & Gosai, M. (2020). Paracetamol vs Ibuprofen in Hemodynamically Significant Patent Ductus Arteriosus (HsPDA) in Preterms: A Randomized Controlled Trial. Asian Journal of Pediatric Research, 3(1), 6-13.
Original Research Article


Van Overmeire B, Van de Broek H, Van Laer P, Weyler J, Vanhaesebrouck P. Early versus late indomethacin treatment for patent ductus arteriosus in premature infants with respiratory distress syndrome. J Pediatr 2001;138(2): 205-11.

Fanaroff AA, Stoll BJ, Wright LL, Carlo WA, Ehrenkranz RA, Stark AR, et al. Trends in neonatal morbidity and mortality for very low birth weight infants. Am J Obstet Gynecol. 2007;196(2):147e1-8.

Clyman RI. Mechanisms regulating the ductus arteriosus. Neonatology. 2006; 89(4):330-5

Skelton R, Evans N, Smythe J. A blinded comparison of clinical and echocardiographic evaluation of the preterm infant for patent ductus arteriosus. J Paediatr Child Health. 1994;30:406–411.

Shah SS, Ohlsson A. Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants. Cochrane Database Syst Rev. 2003;2.

Noori S. Patent ductus arteriosus in the preterm infant: To treat or not to treat? J Perinatol. 2010;30(S1):S31.

Gokmen T, Erdeve O, Altug N, Oguz SS, Uras N, Dilmen U. Efficacy and safety of oral versus intravenous ibuprofen in very low birth weight preterm infants with patent ductus arteriosus. J pediatr. 2011;158(4): 549-54.

Zecca E, Romagnoli C, De Carolis MP, Costa S, Marra R, De Luca D. Does ibuprofen increase neonatal hyperbilirubinemia?. Pediatrics. 2009; 124(2):480-4.

Erdeve O, Sarici SU, Sari E, Gok F. Oral-ibuprofen-induced acute renal failure in a preterm infant. Pediatric Nephrology. 2008; 23(9):1565-7.

Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PloS one. 2013 ;8(11):e77888.

Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, et al. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: RCT. J Pediatr. 2014;164(3):510-4.

Sinha R, Negi V, Dalal SS. An interesting observation of PDA closure with oral paracetamol in preterm neonates. J Clin Neonatol. 2013;2:30-32.

Hammerman C, Bin-Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics. 2011;128(6):1618 21.

Ohlsson A, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database of Systematic Reviews. 2018;Issue4:Art. No.:CD010061.
DOI: 10.1002/14651858.CD010061.pub3

Bauer AZ, Kriebel D. Prenatal and perinatal analgesic exposure and autism: An ecological link. Environmental Health. 2013 ;12(1):41.