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Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates.
Eur J Pediatr. 2017 Feb; 176(2):233-240.EJ

Abstract

In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P < 0.001). There was a significant reduction in platelet count and urine output (UOP) in both ibuprofen and indomethacin groups (P < 0.001). There was a significant increase in bilirubin levels in only the ibuprofen group (P = 0.003). No significant difference of hemoglobin (HB) level or liver enzymes in all groups (P > 0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P < 0.001).

CONCLUSION

Paracetamol is as effective as indomethacin and ibuprofen in closure of PDA in preterm neonates and has less side effects mainly on renal function, platelet count, and GIT bleeding. What is Known: • Hemodynamically significant patent ductus arteriosus has many complications for preterm and low birth weight neonates and better to be closed. Many drugs were used for medical closure of PDA e.g. indomethacin, ibuprofen and recently paracetamol. Many studies compare safety and efficacy of paracetamol with either indomethacin or ibuprofen. What is New: • It is the first large study that compares the efficacy and side effects of the three drugs in one study.

Authors+Show Affiliations

Pediatric Department, Tanta University Hospital, Elgeish street, Tanta, Egypt.Pediatric Department, Tanta University Hospital, Elgeish street, Tanta, Egypt.Pediatric Department, Tanta University Hospital, Elgeish street, Tanta, Egypt. doaamoha@yahoo.com.Pediatric Department, Tanta University Hospital, Elgeish street, Tanta, Egypt.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28004188

Citation

El-Mashad, Abd El-Rahman, et al. "Comparative Study of the Efficacy and Safety of Paracetamol, Ibuprofen, and Indomethacin in Closure of Patent Ductus Arteriosus in Preterm Neonates." European Journal of Pediatrics, vol. 176, no. 2, 2017, pp. 233-240.
El-Mashad AE, El-Mahdy H, El Amrousy D, et al. Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. Eur J Pediatr. 2017;176(2):233-240.
El-Mashad, A. E., El-Mahdy, H., El Amrousy, D., & Elgendy, M. (2017). Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. European Journal of Pediatrics, 176(2), 233-240. https://doi.org/10.1007/s00431-016-2830-7
El-Mashad AE, et al. Comparative Study of the Efficacy and Safety of Paracetamol, Ibuprofen, and Indomethacin in Closure of Patent Ductus Arteriosus in Preterm Neonates. Eur J Pediatr. 2017;176(2):233-240. PubMed PMID: 28004188.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates. AU - El-Mashad,Abd El-Rahman, AU - El-Mahdy,Heba, AU - El Amrousy,Doaa, AU - Elgendy,Marwa, Y1 - 2016/12/21/ PY - 2016/06/13/received PY - 2016/12/12/accepted PY - 2016/12/07/revised PY - 2016/12/23/pubmed PY - 2017/8/12/medline PY - 2016/12/23/entrez KW - Ibuprofen KW - Indomethacin KW - PDA closure KW - Paracetamol KW - Preterm neonate SP - 233 EP - 240 JF - European journal of pediatrics JO - Eur. J. Pediatr. VL - 176 IS - 2 N2 - : In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P < 0.001). There was a significant reduction in platelet count and urine output (UOP) in both ibuprofen and indomethacin groups (P < 0.001). There was a significant increase in bilirubin levels in only the ibuprofen group (P = 0.003). No significant difference of hemoglobin (HB) level or liver enzymes in all groups (P > 0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P < 0.001). CONCLUSION: Paracetamol is as effective as indomethacin and ibuprofen in closure of PDA in preterm neonates and has less side effects mainly on renal function, platelet count, and GIT bleeding. What is Known: • Hemodynamically significant patent ductus arteriosus has many complications for preterm and low birth weight neonates and better to be closed. Many drugs were used for medical closure of PDA e.g. indomethacin, ibuprofen and recently paracetamol. Many studies compare safety and efficacy of paracetamol with either indomethacin or ibuprofen. What is New: • It is the first large study that compares the efficacy and side effects of the three drugs in one study. SN - 1432-1076 UR - https://www.unboundmedicine.com/medline/citation/28004188/Comparative_study_of_the_efficacy_and_safety_of_paracetamol_ibuprofen_and_indomethacin_in_closure_of_patent_ductus_arteriosus_in_preterm_neonates_ L2 - https://dx.doi.org/10.1007/s00431-016-2830-7 DB - PRIME DP - Unbound Medicine ER -