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J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.

Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial.

Author information

1
Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Electronic address: dryekta@gmail.com.
2
Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
3
Division of Neonatology, Department of Pediatrics, Ankara University School of Medicine, Ankara, Turkey.
4
Division of Pediatric Cardiology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
5
Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey; Department of Pediatrics, Yildirim Beyazit University School of Medicine, Ankara, Turkey.

Abstract

OBJECTIVE:

To compare the efficacy and safety of oral paracetamol and oral ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants.

STUDY DESIGN:

This prospective, randomized, controlled study enrolled 90 preterm infants with gestational age ≤ 30 weeks, birthweight ≤ 1250 g, and postnatal age 48 to 96 hours who had echocardiographically confirmed significant PDA. Each enrolled patient received either oral paracetamol (15 mg/kg every 6 hours for 3 days) or oral ibuprofen (initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours).

RESULTS:

Spontaneous closure rate for the entire study group was 54%. After the first course of treatment, the PDA closed in 31 (77.5%) of the patients assigned to the oral ibuprofen group vs 29 (72.5%) of those enrolled in the oral paracetamol group (P = .6). The reopening rate was higher in the paracetamol group than in the ibuprofen group, but the reopening rates were not statistically different (24.1% [7 of 29] vs 16.1% [5 of 31]; P = .43). The cumulative closure rates after the second course of drugs were high in both groups. Only 2 patient (2.5%) in the paracetamol group and 3 patients (5%) in the ibuprofen group required surgical ligation.

CONCLUSION:

This randomized, controlled clinical study compared oral paracetamol with ibuprofen in preterm infants and demonstrated that paracetamol may be a medical alternative in the management of PDA.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01536158.

PMID:
24359938
DOI:
10.1016/j.jpeds.2013.11.008
[Indexed for MEDLINE]

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