The Comparison Between Intravenous Acetaminophen Versus Oral Ibuprofen in Preterm Newborns With Patent Ductus Arteriosus: A Clinical Trial
-
Behzad Mohammadpour Ahranjani
,
Hosein Dalili
,
Zeinab Harif Nashtifani
,
Mamak Shariat
,
Mohammadrafie Khorgami
Abstract
Oral ibuprofen has been known as a conventional treatment for closing patent ductus arteriosus (PDA) in preterm newborns. Since the use of it might lead to various side effects, other treatments needed to be evaluated. Therefore in a prospective study, we compared the efficacy and safety of intravenous acetaminophen versus oral ibuprofen for the closure of PDA. In this study which was done prospectively and under control, 50 preterm neonates with gestational ages and weights less than 37 weeks old and 2500 grams, respectively, who had PDA, large enough hemodynamically, were included in the study. The patients were divided into two groups: A (intravenous acetaminophen) & B (oral ibuprofen). The two groups were given at most two 3-day courses of the medication (the second course if necessary) and evaluated at the end of each course by echocardiography so as to determine the response to the treatment at each step. The rate of ductal closure, the need for additional treatment, side effects, complications and the newborn’s clinical status were recorded. The rate of ductal closure in the both groups after one course of treatment was similar and showed no meaningful significance statistically (P=0.306). But that of the side effects was much higher in group B with a P=0.021. Intravenous Acetaminophen is not only as efficacious as oral Ibuprofen for the treatment of PDA in preterm infants, but also is less likely to lead to side effects and complications.
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2. The Vermont- Oxford Trials Network: very low birth weight outcomes for 1990. Pediatrics 1993;91:540-5.
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9. Koch J, Hensley G, Roy L, Brown S, Ramaciotti G, Rosenfeld CR. Prevalence of spontaneous closure of the ductus arteriosus in neonates at birth weight of 1000 grams or less. Pediatrics 2006;117:1113-21.
10. Herrman K, Bose C, Lewis K, Laughon M. Spontaneous closure of the patent ductus arteriosus in very low birth weight infants following discharge from the neonatal unit. Arch Dis Child Fetal Neonatal Ed 2009;94:F48-50.
11. Clyman RI. Ibuprofen and patent ductus arteriosus. N Engl J Med 2000;343:728-30.
12. Schneider DJ, Moore JW. Patent ductus arteriosus. Circulation 2006;114:1873-82.
13. Weir EK, Lopez-Barneo J, Buckler KJ, Archer SL. Acute oxygen- sensing mechanisms. N Engl J Med 2005;353:2042-55.
14. Thebaud B, Michelakis ED, Wu XC, Moudgil R, Kuzyk M, Dyck JRB, et al. Oxygen sensitive Kv channel gene transfer confers oxygen responsiveness to preterm rabbit and remodeled human ductus arteriosus: implications for infants with patent ductus arteriosus. Circulation 2004;110:1372-9.
15. Thebaud B, Wu XC, Kajimoto H, Bonnet S, Hashimoto K, Michelakis ED, et al. Developmental absence of the O2 sensivity of L-type calcium channels in preterm ductus arteriosus smooth muscle cells impairs O2 constriction contributing to patent ductus arteriosus. Pediatr Res 2008;63:176-81.
16. Hong Z, Hong F, Olschewski A, Cabrera JA, Varghese A, Nelson DP, et al. Role of store operated calcium channels and calcium sensitization in normoxic contraction of the ductus arteriosus. Circulation 2006;114:1372-9.
17. Kajimoto H, Hashimoto K, Bonnet SN, Haromy A, Harry G, Moudgil R, et al. oxygen activates the Rho/Rho kinase pathway and induces RhoB and Rock-1 expression in human and rabbit ductus arteriosus by increasing mitochondria- derived reactive oxygen species: a newly recognised mechanism for sustaining ductal constriction. Circulation 2007;115:1777-88.
18. Michelakis E, Rebeyka I, Bateson J, Olley P, Puttagunta L, Archer S. Voltage- gated potassium channels in human ductus arteriosus. Lancet 2000;356:134-7.
19. Clyman RI. Ibuprofen and patent ductus arteriosus. N Engl J Med 2000;343:728-30.
20. Liu H, Manganiello V, Waleh N, Clyman RI. Expression, activity and function of phosphodiestrases in the mature and immature ductus arteriosus. Pediatr Res 2008;64:477-81.
21. De Felice C, Bechelli S, Tonni G, Hansmann G. Systematic underestimation of oxygen delivery in ventilated preterm infants. Neonatology 2009;98:18-22.
22. Noori S, McCoy M, Friedlich P, Bright B, Gottipati V, Seri I, et al. Failure of ductus arteriosus closure is associated with increased mortality in preterm infants. Pediatrics 2009;123:e138-44.
23. Tacy TA. Abnormalities of the ductus arteriosus and pulmonary arteries. In: Lai WW, Mertens LL, Cohen MS, Geva T, eds. Echocardiography in pediatric and congenital heart disease. West sussex, United Kingdom: Wiley-Blackwell, 2009:283-96.
24. EI Hajjar M, Vaksmann G, Rakza T, Kongolo G, Storme L. Severity of the ductal shunt: a comparison of different markers. Arch Dis Child Fetal Neonatal Ed 2005;90:F419-22.
25. EI-Khuffash A, Barry D, Walsh K, Davis PG, Molloy EJ. Biochemical markers may identify preterm infants with a patent ductus arteriosus at high risk of death or severe intraventricular hemorrhage. Arch Dis Child Fetal Neonatal Ed 2008;93:F407-12.
26. Rheinlaender C, Helfenstein D, Walch E, Berns M, Obladen M, Koehne P. Total serum bilirubin levels during cyclooxygenase inhibitor treatment for patent ductus arteriosus in preterm infants. Acta Paediatr 2009;98:36-42.
27. Schmidt B, Roberts RS, Fanaroff A. Indomethacin prophylaxis, patent ductus arteriosus, and the risk of bronchopulmonary dysplasia: further analyses from the trial of indomethacin prophylaxis in preterms (TIPP). J Pediatr 2006;148:730-4.
28. Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. Plos One 2013;8:e778-88.
29. Lucas R, Warner TD, Vojnovic I, Mitchell JA. Cellular mechanisms of acetaminophen: role of cyclooxygenase. FASEB J 2005;19:635-7.
30. Dash SK, Kabra NS, Avashthi BS, Sharma SR, Padhi P, Ahmed J. Enteral paracetamol or intravenous indomethacin for closure of patent ductus arteriosus in preterm neonates: a randomized controlled study. Indian Pediatr 2015;52:573-8.
31. Jones L J, Craven PD, Attia J, Thakkinstian A, Wright I. Network meta- analyses of indomethacin versus ibuprofen versus placebo for PDA in preterm infants. Arch Dis Child Fetal Neonatal 2010;164:135-40.
32. Hammerman C, Bin- Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D, et al. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics 2011;128:e1618-21.
33. Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. Plos One 2013;8:e778-88.
34. Oncel MY, Yurtuttan S, Degirmencioglu H, Uras N, Altug N, Erdeve O, Dilmen U. Intravenous paracetamol treatment in the management of patent ductus arteriosus in extremely low birth weight infants. Neonatology 2013;103:166-9.
35. 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. a randomized controlled trial. J Pediatr 2014;164:510-4.
36. Manyike PT, Kharasch ED, Kalhorn TF, Slattery JT. Contribution of CYP2E1 and CYP3A to acetaminophen reactive metabolite formation. Clin Pharmacol Ther 2000;67: 275-82.
37. Allegaert K, Anderson BJ, Naulaers G, de hoon J, Verbesselt R, Debeer A, et al. Intravenous paracetamol ( Propacetamol) pharmacokinetics in term and preterm babies. Eur J Clin Pharmacol 2004;60:191-7.
2. The Vermont- Oxford Trials Network: very low birth weight outcomes for 1990. Pediatrics 1993;91:540-5.
3. Hamrick SEG, Hansmann G. Patent Ductus Arteriosus of the Preterm Infant. Pediatrics 2010 125:10207.
4. Hermes- Desantis ER, Clyman RI. Patent ductus arteriosus: Pathophysiology and management. J Perinatol 2006;26:S 14-8.
5. Skinner J. Diagnosis of patent ductus arteriosus. Semin Neonatol 2001;6:49-61.
6. Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol 2002;39:1890-900.
7. Hamrick SEG, Hansmann G. Patent ductus arteriosus of the preterm infant. Pediatrics 2010;125:1020-30.
8. Richards J, Johnson A, Fox G, Campbell M. A second course of ibuprofen is effective in the closure of a clinically significant PDA in ELBW infants. Pediatrics 2009;124:e287-93.
9. Koch J, Hensley G, Roy L, Brown S, Ramaciotti G, Rosenfeld CR. Prevalence of spontaneous closure of the ductus arteriosus in neonates at birth weight of 1000 grams or less. Pediatrics 2006;117:1113-21.
10. Herrman K, Bose C, Lewis K, Laughon M. Spontaneous closure of the patent ductus arteriosus in very low birth weight infants following discharge from the neonatal unit. Arch Dis Child Fetal Neonatal Ed 2009;94:F48-50.
11. Clyman RI. Ibuprofen and patent ductus arteriosus. N Engl J Med 2000;343:728-30.
12. Schneider DJ, Moore JW. Patent ductus arteriosus. Circulation 2006;114:1873-82.
13. Weir EK, Lopez-Barneo J, Buckler KJ, Archer SL. Acute oxygen- sensing mechanisms. N Engl J Med 2005;353:2042-55.
14. Thebaud B, Michelakis ED, Wu XC, Moudgil R, Kuzyk M, Dyck JRB, et al. Oxygen sensitive Kv channel gene transfer confers oxygen responsiveness to preterm rabbit and remodeled human ductus arteriosus: implications for infants with patent ductus arteriosus. Circulation 2004;110:1372-9.
15. Thebaud B, Wu XC, Kajimoto H, Bonnet S, Hashimoto K, Michelakis ED, et al. Developmental absence of the O2 sensivity of L-type calcium channels in preterm ductus arteriosus smooth muscle cells impairs O2 constriction contributing to patent ductus arteriosus. Pediatr Res 2008;63:176-81.
16. Hong Z, Hong F, Olschewski A, Cabrera JA, Varghese A, Nelson DP, et al. Role of store operated calcium channels and calcium sensitization in normoxic contraction of the ductus arteriosus. Circulation 2006;114:1372-9.
17. Kajimoto H, Hashimoto K, Bonnet SN, Haromy A, Harry G, Moudgil R, et al. oxygen activates the Rho/Rho kinase pathway and induces RhoB and Rock-1 expression in human and rabbit ductus arteriosus by increasing mitochondria- derived reactive oxygen species: a newly recognised mechanism for sustaining ductal constriction. Circulation 2007;115:1777-88.
18. Michelakis E, Rebeyka I, Bateson J, Olley P, Puttagunta L, Archer S. Voltage- gated potassium channels in human ductus arteriosus. Lancet 2000;356:134-7.
19. Clyman RI. Ibuprofen and patent ductus arteriosus. N Engl J Med 2000;343:728-30.
20. Liu H, Manganiello V, Waleh N, Clyman RI. Expression, activity and function of phosphodiestrases in the mature and immature ductus arteriosus. Pediatr Res 2008;64:477-81.
21. De Felice C, Bechelli S, Tonni G, Hansmann G. Systematic underestimation of oxygen delivery in ventilated preterm infants. Neonatology 2009;98:18-22.
22. Noori S, McCoy M, Friedlich P, Bright B, Gottipati V, Seri I, et al. Failure of ductus arteriosus closure is associated with increased mortality in preterm infants. Pediatrics 2009;123:e138-44.
23. Tacy TA. Abnormalities of the ductus arteriosus and pulmonary arteries. In: Lai WW, Mertens LL, Cohen MS, Geva T, eds. Echocardiography in pediatric and congenital heart disease. West sussex, United Kingdom: Wiley-Blackwell, 2009:283-96.
24. EI Hajjar M, Vaksmann G, Rakza T, Kongolo G, Storme L. Severity of the ductal shunt: a comparison of different markers. Arch Dis Child Fetal Neonatal Ed 2005;90:F419-22.
25. EI-Khuffash A, Barry D, Walsh K, Davis PG, Molloy EJ. Biochemical markers may identify preterm infants with a patent ductus arteriosus at high risk of death or severe intraventricular hemorrhage. Arch Dis Child Fetal Neonatal Ed 2008;93:F407-12.
26. Rheinlaender C, Helfenstein D, Walch E, Berns M, Obladen M, Koehne P. Total serum bilirubin levels during cyclooxygenase inhibitor treatment for patent ductus arteriosus in preterm infants. Acta Paediatr 2009;98:36-42.
27. Schmidt B, Roberts RS, Fanaroff A. Indomethacin prophylaxis, patent ductus arteriosus, and the risk of bronchopulmonary dysplasia: further analyses from the trial of indomethacin prophylaxis in preterms (TIPP). J Pediatr 2006;148:730-4.
28. Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. Plos One 2013;8:e778-88.
29. Lucas R, Warner TD, Vojnovic I, Mitchell JA. Cellular mechanisms of acetaminophen: role of cyclooxygenase. FASEB J 2005;19:635-7.
30. Dash SK, Kabra NS, Avashthi BS, Sharma SR, Padhi P, Ahmed J. Enteral paracetamol or intravenous indomethacin for closure of patent ductus arteriosus in preterm neonates: a randomized controlled study. Indian Pediatr 2015;52:573-8.
31. Jones L J, Craven PD, Attia J, Thakkinstian A, Wright I. Network meta- analyses of indomethacin versus ibuprofen versus placebo for PDA in preterm infants. Arch Dis Child Fetal Neonatal 2010;164:135-40.
32. Hammerman C, Bin- Nun A, Markovitch E, Schimmel MS, Kaplan M, Fink D, et al. Ductal closure with paracetamol: a surprising new approach to patent ductus arteriosus treatment. Pediatrics 2011;128:e1618-21.
33. Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. Plos One 2013;8:e778-88.
34. Oncel MY, Yurtuttan S, Degirmencioglu H, Uras N, Altug N, Erdeve O, Dilmen U. Intravenous paracetamol treatment in the management of patent ductus arteriosus in extremely low birth weight infants. Neonatology 2013;103:166-9.
35. 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. a randomized controlled trial. J Pediatr 2014;164:510-4.
36. Manyike PT, Kharasch ED, Kalhorn TF, Slattery JT. Contribution of CYP2E1 and CYP3A to acetaminophen reactive metabolite formation. Clin Pharmacol Ther 2000;67: 275-82.
37. Allegaert K, Anderson BJ, Naulaers G, de hoon J, Verbesselt R, Debeer A, et al. Intravenous paracetamol ( Propacetamol) pharmacokinetics in term and preterm babies. Eur J Clin Pharmacol 2004;60:191-7.
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| Issue | Vol 58, No 12 (2020) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/acta.v58i12.5155 | |
| Keywords | ||
| Patent Ductus Arteriosus Acetaminophen Preterm infants | ||
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How to Cite
1.
Ahranjani B, Dalili H, Nashtifani Z, Shariat M, Khorgami M. The Comparison Between Intravenous Acetaminophen Versus Oral Ibuprofen in Preterm Newborns With Patent Ductus Arteriosus: A Clinical Trial. Acta Med Iran. 2021;58(12):631-636.
