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Arch Dis Child Fetal Neonatal Ed. 2016 Mar;101(2):F127-36. doi: 10.1136/archdischild-2014-307312. Epub 2015 Aug 17.

Paracetamol for the treatment of patent ductus arteriosus in preterm neonates: a systematic review and meta-analysis.

Author information

1
Department of Gynecology-Obstetrics and Perinatal Medicine, Sapienza University of Rome, Rome, Italy.
2
Department of Pediatrics and Pediatric Neuropsychiatry, Sapienza University of Rome, Rome, Italy.
3
Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
4
Department of Neonatology, The Hospital for Sick Children, Toronto, Canada.
5
Division of Neonatology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.
6
Department of Pediatrics and Neonatology, 167 Military Hospital, Pathankot, Punjab, India.
7
Division of Neonatology, Department of Pediatrics, Ankara University School of Medicine Children's Hospital, Ankara, Turkey.
8
Department of Neonatology, Ataturk University Medical Faculty, Erzurum, Turkey.
9
Division of Cardiology, Department of Pediatrics, Pamukkale University, Denizli, Turkey.
10
Department of Neonatology, Carmel Medical Center, Haifa, Israel.
11
Department of Neonatology, Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel.
12
Department of Neonatology, Hillel Yaffe Medical Center, Hadera, Israel.
13
Department of Neonatology, KEM Hospital, Mumbai, India.
14
Division of Neonatology, Hitit University, Corum, Turkey.
15
Division of Gastroenterology, Cardarelli Hospital, Naples, Italy.

Abstract

OBJECTIVES:

We performed a systematic review and meta-analysis of all the available evidence to assess the efficacy and safety of paracetamol for the treatment of patent ductus arteriosus (PDA) in neonates, and to explore the effects of clinical variables on the risk of closure.

DATA SOURCE:

MEDLINE, Scopus and ISI Web of Knowledge databases, using the following medical subject headings and terms: paracetamol, acetaminophen and patent ductus arteriosus. Electronic and manual screening of conference abstracts from international meetings of relevant organisations. Manual search of the reference lists of all eligible articles.

STUDY SELECTION:

Studies comparing paracetamol versus ibuprofen, indomethacin, placebo or no intervention for the treatment of PDA.

DATA EXTRACTION:

Data regarding efficacy and safety were collected and analysed.

RESULTS:

Sixteen studies were included: 2 randomised controlled trials (RCTs) and 14 uncontrolled studies. Quality of selected studies is poor. A meta-analysis of RCTs does not demonstrate any difference in the risk of ductal closure (Mantel-Haenszel model, RR 1.07, 95% CI 0.87 to 1.33 and RR 1.03, 95% CI 0.92 to 1.16, after 3 and 6 days of treatment, respectively). Proportion meta-analysis of uncontrolled studies demonstrates a pooled ductal closure rate of 49% (95% CI 29% to 69%) and 76% (95% CI 61% to 88%) after 3 and 6 days of treatment with paracetamol, respectively. Safety profiles of paracetamol and ibuprofen are similar.

CONCLUSIONS:

Efficacy and safety of paracetamol appear to be comparable with those of ibuprofen. These results should be interpreted with caution, taking into account the non-optimal quality of the studies analysed and the limited number of neonates treated with paracetamol so far.

KEYWORDS:

Cardiology; Intensive Care; Neonatology; Therapeutics

[Indexed for MEDLINE]

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