A COMPREHENSIVE STUDY TO CHECK THE EFFICACY OF INTRAVENOUS PARACETAMOL AND IBUPROFEN IN TREATING PATENT DUCTUS ARTERIOSUS IN PRETERM BABIES

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Bhattacharyya S, Kurian V
Dr Saptarshi Bhattacharyya
Dr Vignesh Kurian

Keywords

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Abstract

We set out to evaluate the safety and effectiveness of intravenous (i.v.) paracetamol in comparison to other methods. ibuprofen for the management of premature neonates with hemodialysis-significant patent ductus arteriosus (hsPDA). This research held on infants between the ages of 20 and 35 weeks were randomly assigned to undergo intravenous treatment either intravenous (IV) paracetamol 12 mg/kg/6 h for three days or 8-4-4 mg/kg/day of ibuprofen. The main result was the percentage of hsPDA  following the initial course of therapy with ibuprofen or paracetamol. The necessity for surgical closure, the re-opening rate, and the constriction rate of hsPDA were among the secondary results. Ibuprofen was given to 96 newborns and paracetamol to 114 infants. Logistic regression analysis indicated that while ibuprofen was more successful in closing hsPDA than paracetamol ( P = 0.037), the ductus constriction rate was equal ( P = 0.242). Similarities also existed in the rate of reopening, the requirement for surgical closure, and the incidence of side effects. Although ibuprofen was more efficient than intravenous paracetamol in closing hsPDA, the use of paracetamol was linked to the same hsPDA result because of a similar constriction effect. The first-choice medication for the treatment of hsPDA is paracetamol.

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References

1. Hamrick SE, Hansmann G. Patent ductus arteriosus of the preterm infant. Pediatrics. 2010;125:1020-30.
2. Itabashi K, Ohno T, Nishida H. Indomethacin responsiveness of patent ductus arteriosus and renal abnormalities in preterm infants treated with indomethacin. J Pediatr. 2003;143:203-7.
3. Raval MV, Laughon MM, Bose CL, Phillips JD. Patent ductus arteriosus ligation in premature infants: who really benefits, and at what cost? J Pediatr Surg. 2007;42:69-75.
4. Ohlsson A, Walia R, Shah SS. Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight (or both) infants. Cochrane Database Syst Rev. 2015;2, CD003481.
5. Gournay V, Roze JC, Kuster A, Daoud P, Cambonie G, Hascoet JM, et al. Prophylactic ibuprofen versus placebo in very premature infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2004;364:1939-44.
6. Zecca E, Romagnoli C, De Carolis M, Costa S, Marra R, De Luca D. Does Ibuprofen increase neonatal hyperbilirubinemia? Pediatrics. 2009;124:480-4.
7. Rheinlaender C, Helfenstein D, Walch E, Berns M, Obladen M, Koehne P.
8. Total serum bilirubin levels during cyclooxygenase inhibitor treatment for patent ductus arteriosus in preterm infants. Acta Paediatr. 2009;98:36-42.
9. Johnston PG, Gillam-Krakauer M, Fuller MP, Reese J. Evidence-based use of indomethacin and ibuprofen in the neonatal intensive care unit. Clin Perinatol. 2012;39:111-36.
10. Hammerman C, Bin-Nun A, Kaplan M. Managing the patent ductus arteriosus in the premature neonate: a new look at what we thought we knew. Semin Perinatol. 2012;36:130-8.
11. Thomas RL, Parker GC, Van Overmeire B, Aranda JV. A meta-analysis of ibuprofen versus indomethacin for closure of patent ductus arteriosus. Eur J Pediatr. 2005;164:135-40.
12. Bartocci M, Lundberg S. Intravenous paracetamol: the’Stockholm protocol’ for postoperative analgesia of term and preterm neonates. Pediatr Anesth. 2007;17(11):1120-1.
13. Wilson-Smith EM, Morton NS. Survey of i.v. paracetamol (acetaminophen) use in neonates and infants under 1 year of age by UK anesthetists. Pediatr Anesth. 2009;19(4):329-37.
14. 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):e1618-21.
15. Sinah R, Negi V, Dalal SS. An interesting observation of PDA closure with oral paracetamol in preterm neonates. J Clin Neonatol. 2013;2(1):30-2.
16. Yurttutan S, Oncel MY, Arayici S, Uras N, Altug N, Erdeve O, et al. A different first-choice drug in the medical management of patent ductus arteriosus: oral paracetamol. J Maternal Fetal Neonatal Med. 2013;26(8):825-7.
17. Nadir E, Kassem E, Foldi S, Hochberg A, Feldman M. Paracetamol treatment of patent ductus arteriosus in preterm infants. J Perinatol. 2014;34(10):748-9.
18. Kessel I, Waisman D, Lavie-Nevo K, Golzman M, Lorber A, Rotschild A. Paracetamol effectiveness, safety and blood level monitoring during patent ductus arteriosus closure: a case series. J Matern-Fetal Neo Med. 2014;27(16): 1719-21.
19. El-Khuffash A, Jain A, Corcoran D, Shah PS, Hooper CW, Brown N, et al. Efficacy of paracetamol on patent ductus arteriosus closure may be dose dependent: evidence from human and murine studies. Pediatr Res. 2014; 76(3):238-44.
20. Wang C, Allegaert K, Tibboel D, Danhof M, van der Marel CD, Mathot RAA, et al. Population pharmacokinetics of paracetamol across human age-ranges from (pre)term neonates, infants, children to adults. J Clin Pharmacol. 2014;54:619-29.
21. Goldstein B, Giroir B, Randolph A. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005;6:2-8.