Comparison of Oral Paracetamol with Oral Ibuprofen in Closing Patent Ductus Arteriosus in Premature Neonates: A Randomized Controlled Trial

Mahmoud Samadi; Kayvan Mirnia; Zahra Nabaie; Armin Salek Maghsoudi; Reza Aliakbari Khoei; Razieh Parizad

doi:10.34172/cjmb.2022.17

E-ISSN : 2148-9696

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Original Article
Comparison of Oral Paracetamol with Oral Ibuprofen in Closing Patent Ductus Arteriosus in Premature Neonates: A Randomized Controlled Trial
Mahmoud Samadi¹, Kayvan Mirnia², Zahra Nabaie¹, Armin Salek Maghsoudi³, Reza Aliakbari Khoei⁴, Razieh Parizad⁵
¹Department of Pediatrics, Pediatric Health Research Center, Tabriz University of Medical Science, Tabriz, Iran ²Department of Pediatrics, Tehran University of Medical Science, Tehran, Iran ³Department of Toxicology and Pharmacology, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran ⁴Department of Biostatics, Faculty of Medical Science, Tarbiat Modaress University, Tehran, Iran ⁵Department of Nursing, Faculty of Nursing and Midwifery, Tabriz University of Medical Science, Tabriz, Iran
CJMB 2022; 9: 098-103 DOI: 10.34172/cjmb.2022.17 Viewed : 2598 times Downloaded : 2397 times. Keywords : Acetaminophen, Ibuprofen, Patent ductus arteriosus, Premature infant
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Abstract

Objectives: Patent ductus arteriosus (PDA) is one of the most common congenital heart diseases. Physiologically, the closure of the ductus arteriosus occurs within 48-72 hours after birth in healthy term neonates. This study aimed to compare oral paracetamol and oral ibuprofen in the closure of PDA in preterm neonates. Materials and Methods: This study is a single-blind randomized clinical trial. A total of 90 preterm neonates with a gestational age of less than 32 weeks were divided into two groups of oral ibuprofen and oral paracetamol. Oral ibuprofen was administered at a dose of 10 mg/kg on the first day and 5 mg/kg on the second and the third days. Oral paracetamol was administered at a dose of 10 mg/kg every 6 hours for 3 consecutive days. The primary outcome measure was the closure of the ductus arteriosus. The secondary outcome measure was the assessment of any type of complications following the administration of oral paracetamol. Results: The DA closure rate was 82.2% in the oral paracetamol group and it was 91.41% in the oral ibuprofen group P<0.65, (odds ratio [OR] = 2.22, 95% CI = 0.62-7.97). We did not see any unwanted complication during treatment with oral paracetamol. Conclusions: The present study showed that oral paracetamol is effective in the closure of PDA. On the other hand, it does not cause any unwanted side effects on the patient.