Oral Ibuprofen for Treatment of Patent Ductus Arteriosus: More than a Cheap Alternative

Erdeve, Ömer; Yurttutan, Sadık; Оздемир, Рамазан; Dilmen, Uğur

doi:10.1159/000339552

Cited by 4 publications

(1 citation statement)

References 5 publications

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“…The most commonly used drugs for this purpose are cyclooxygenase inhibitors, mainly indomethacin and ibuprofen, which block the conversion of arachidonic acid to prostaglandins [1,2]. The reported treatment success with ibuprofen for the management of hsPDA is between 70 and 85% [3,4,5,6]. On the other hand, several adverse effects have been reported with such medications, including peripheral vasoconstriction, gastrointestinal bleeding and perforation, weakened platelet aggregation, hyperbilirubinemia and renal failure [7,8].…”

Section: Introductionmentioning

confidence: 99%

Intravenous Paracetamol Treatment in the Management of Patent Ductus Arteriosus in Extremely Low Birth Weight Infants

Öncel¹,

Yurttutan²,

Değirmencioğlu³

et al. 2012

Neonatology

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112

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Background: Treatment options for the closure of a hemodynamically significant patent ductus arteriosus (hsPDA) include medical therapy such as ibuprofen and indomethacin and surgical ligation. Objective: To evaluate the efficacy of intravenous paracetamol in preterm infants with hsPDA whose feeding was contraindicated or had feeding intolerance. Methods: Preterm infants with hsPDA were started on intravenous paracetamol treatment with parental consent. Paracetamol was administered at a dose of 60 mg/kg/day, in four divided doses, for a period of 3 days. In the absence of closure of hsPDA, treatment was extended up to 6 days, after which echocardiographic examination was performed. Results: A total of 10 preterm infants were included in the study with a median gestational age of 27^4/7 weeks (minimum–maximum: 24–29) and a median birth weight of 775 g (590–990). The first dose of intravenous paracetamol was given after a median of 6 days (2–15). On echocardiographic examination, median internal ductal diameter was 2 mm (1.5–3), with a median left atrium-to-aortic root ratio of 1.95 (1.6–2.2). Intravenous paracetamol resulted in successful closure of hsPDA in all patients. Conclusions: This study is the first case series in the literature which used intravenous paracetamol treatment for hsPDA. We believe that intravenous paracetamol could be used as an alternative drug for infants. Further prospective randomized-controlled trials are needed to evaluate the efficacy of intravenous paracetamol for the closure of hsPDA.

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Section: Introductionmentioning

confidence: 99%

Intravenous Paracetamol Treatment in the Management of Patent Ductus Arteriosus in Extremely Low Birth Weight Infants

Öncel¹,

Yurttutan²,

Değirmencioğlu³

et al. 2012

Neonatology

Self Cite

112

View full text Add to dashboard Cite

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Oral Paracetamol versus Oral Ibuprofen in the Management of Patent Ductus Arteriosus in Preterm Infants: A Randomized Controlled Trial

Öncel

Yurttutan

Erdeve

et al. 2014

The Journal of Pediatrics

176

159

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Oral paracetamol versus oral ibuprofen for closure of haemodynamically significant patent ductus arteriosus in preterm neonates (<32 weeks): a blinded, randomised, active-controlled, non-inferiority trial

Kumar

Sundaram

Yadav

et al. 2017

bmjpo

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IntroductionHaemodynamically significant patent ductus arteriosus (hsPDA) is a common cause of mortality and morbidity in preterm infants. Existing medical therapies with ibuprofen or indomethacin have multiple adverse effects. Hence, an alternative drug like paracetamol given through oral route with less side effects need to be tested in an appropriate study design with least risk of bias to arrive at a conclusion.Methods and analysisMultisite, randomised, active-controlled, non-inferiority design. The primary objective is to study the efficacy of oral paracetamol for closure of hsPDA in comparison to oral ibuprofen in preterm neonates of <32 weeks’ gestation. Randomisation web-based and allocation concealment would be done; the treating team, investigators, outcome assessors and laboratory personnel would be blinded from the intervention. Echocardiography images would be coded for independent review. Closure of PDA by the end of last dose of study drug or earlier would be the study endpoint. A sample size of 196 neonates would be enrolled with a non-inferiority margin of 15%. Both intention-to-treat and per-protocol analysis will be done to assess the effect of contamination and protocol violations in the primary outcome.Ethics and disseminationThe trial would follow international code of ethics for clinical trial. The trial protocol was approved by the Institute Ethics Committee of all three centres. All serious adverse events would be reported in detail to the Institute Ethics Committee. A written informed consent would be obtained from one of the parents. No plan has been made for dissemination.Trial registration numberCTRI/2014/08/004805.

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Oral Ibuprofen for Treatment of Patent Ductus Arteriosus: More than a Cheap Alternative

Cited by 4 publications

References 5 publications

Intravenous Paracetamol Treatment in the Management of Patent Ductus Arteriosus in Extremely Low Birth Weight Infants

Intravenous Paracetamol Treatment in the Management of Patent Ductus Arteriosus in Extremely Low Birth Weight Infants

Oral Paracetamol versus Oral Ibuprofen in the Management of Patent Ductus Arteriosus in Preterm Infants: A Randomized Controlled Trial

Oral paracetamol versus oral ibuprofen for closure of haemodynamically significant patent ductus arteriosus in preterm neonates (<32 weeks): a blinded, randomised, active-controlled, non-inferiority trial

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