Key result
Oral paracetamol achieved an 82.2% closure rate of patent ductus arteriosus compared to 91.41% with oral ibuprofen, demonstrating no statistically significant difference (OR 2.22, p<0.65).
Why the study?
Patent ductus arteriosus is a common congenital heart disease in preterm neonates, prompting comparison between oral paracetamol and oral ibuprofen for ductal closure.
Does oral paracetamol improve the closure rate of patent ductus arteriosus in preterm neonates compared to oral ibuprofen?
RCT (n=90)
Single-blind
Randlist software
No
Does oral paracetamol improve the closure rate of patent ductus arteriosus in preterm neonates compared to oral ibuprofen?
Odds Ratio: 2.22 (95% CI 0.62–7.97)
Absolute Event Rate: 82.2% vs 91.41%
p-value: p=<0.65
Oral paracetamol is as effective as oral ibuprofen for closing patent ductus arteriosus in premature neonates, offering a safe alternative when NSAIDs are contraindicated.
Supports oral paracetamol as alternative to ibuprofen for PDA closure in preterm neonates; extends options when NSAIDs are contraindicated.
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.
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Samadi et al. (2020) conducted an RCT in Patent ductus arteriosus (n=90). Oral paracetamol vs. Oral ibuprofen was evaluated on Closure of the ductus arteriosus (OR 2.22, 95% CI 0.62-7.97, p=<0.65). Oral paracetamol achieved an 82.2% closure rate of patent ductus arteriosus compared to 91.41% with oral ibuprofen, demonstrating no statistically significant difference (OR 2.22, p<0.65).
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