|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
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Keywords : Acetaminophen, Ibuprofen, Patent ductus arteriosus, Premature infant
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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.
Conclusion: 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.
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