Efficacy and Safety of Oral Versus Intravenous Ibuprofen in Very Low Birth Weight Preterm Infants with Patent Ductus Arteriosus

Gökmen, Tülin; Erdeve, Ömer; Altuğ, Nahide; Oğuz, Şerife Suna; Uraş, Nurdan; Dilmen, Uğur

doi:10.1016/j.jpeds.2010.10.008

Cited by 101 publications

(107 citation statements)

References 32 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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109

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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

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109

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“…Since the renal tolerability of ibuprofen for renal function in the neonate is a major argument in favour of its use in the treatment of PDA (27,28), our study expands our information about the safety and efficacy of oral ibuprofen in more mature VLBW infants. sCr levels and uremia in our patients were within the normal range at all times, so there was no contraindication for a second or third dose of ibuprofen when it was needed.…”

Section: Discussionmentioning

confidence: 79%

“…This study was not powered to detect differences in complications (25). The two studies increase the number of infants randomized and expand the information about the safety and efficacy of oral ibuprofen in more mature VLBW infants (27,28).…”

Section: Discussionmentioning

confidence: 99%

Treatment strategy of patent ductus arteriosus in preterm infants

Pistuli

Hoxha²,

Bakalli³

et al. 2013

Pediatr Today

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Objective -This study was to assess the efficacy and safety of oral ibuprofen and intravenous ibuprofen for the early pharmacological treatment of patent ductus arteriosus (PDA) in preterm infants. Methods -A randomized, single-blinded, controlled study was performed on premature neonates at the neonatal unit tertiary care hospital, from January 2010 to December 2012. The study enrolled 80 preterm infants with gestational age between 28-32 weeks, birth weight ≤ 2000 g, postnatal age 48-96 h, and with echocardiographically confirmed significant PDA (a duct size >1.5 mm). The preterm infants received either intravenous or oral ibuprofen randomly as an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h after the first dose (the first treatment course). Serum creatinine (sCr), blood urea nitrogen (BUN) and urine output (UO) were recorded prior to treatment, before each dose and after the first treatment course. Results -Forty patients were treated with oral ibuprofen and 40 with intravenous ibuprofen in this period. There was no difference between treatment groups in demographics or baseline renal function. After the first course of the treatment, the PDA closed in 28 (70%) of the patients assigned to the oral ibuprofen group, versus 23 (57.5%) of those enrolled in the intravenous ibuprofen group (p=0.35). In the evaluation of renal tolerance, none of the patients had oliguria. Moreover, in patients who underwent a second course of intravenous therapy, the urinary output significantly decreased, but the sCr levels after the first and after the second treatment course did not differ significantly from the baseline for each group. 7.5% of the intravenous group underwent surgery, versus 0% of the oral group. (p=0.23) Conclusions -Successful pharmacological closure of PDA can be achieved by the use of ibuprofen orally or intravenously, without statistically significant difference in efficacy and safety between the two treatments. Patients treated with ibuprofen intravenously probably have a much higher risk of undergoing surgery.

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“…10 Dari penelitian sebelumnya ditemukan efek samping ibuprofen pada BKB berupa hiperbilirubinemia (35%), 18 trombositopenia (25%), 11 perdarahan saluran cerna (2,5-12,6%), 17,18,20 NEC (3,6%), 20 dan perforasi usus spontan (3%). 21 Pada penelitian kami, kejadian efek samping keseluruhan secara bermakna lebih besar pada pemberian ibuprofen oral dibandingkan parasetamol intravena.…”

Section: Pembahasanunclassified

Perbandingan Efektifitas dan Keamanan Parasetamol Intravena dan Ibuprofen Oral pada Penutupan Duktus Arteriosus Persisten pada Bayi Kurang Bulan

Sari

Nova

Bermawi

et al. 2016

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Latar belakang. Duktus arteriosus persisten (DAP) pada bayi kurang bulan (BKB) dapat menimbulkan gangguan hemodinamika sehingga perlu segera ditutup. Salah satu cara penutupan adalah dengan obat penghambat siklooksigenase (COX), khususnya ibuprofen. Mengingat efek samping yang ditimbulkan ibuprofen, parasetamol yang bekerja menghambat peroksidase mulai diperkenalkan sebagai alternatif dengan efektifitas setara dan efek samping yang minimal. Tujuan. Membandingkan efektifitas dan keamanan antara parasetamol intravena dan ibuprofen oral untuk penutupan DAP pada BKB. Metode. Uji klinis terbuka, acak terkontrol pada bayi dengan usia gestasi ≤37 minggu yang dikonfirmasi DAP dengan menggunakan ekokardiografi. Dilakukan randomisasi blok untuk menerima parasetamol intravena atau ibuprofen oral. Hasil utama yang dinilai adalah respon terapi penutupan duktus arteriosus (DA), efek samping yang timbul, dan kejadian reopening. Hasil. Penutupan DAP terjadi pada 33 dari 36 (91,6%) BKB yang mendapat parasetamol intravena dan 29 dari 40 (72,5%) yang mendapat ibuprofen oral (p=0,03). Pada kelompok ibuprofen, efek samping yang timbul berupa trombositopenia (28,5%) dan perdarahan saluran cerna (25,7%), sedangkan pada kelompok parasetamol intravena tidak dijumpai efek samping. Reopening terjadi hanya pada satu bayi di kelompok ibuprofen oral. Kesimpulan. Parasetamol intravena lebih efektif dan lebih aman dibandingkan ibuprofen oral untuk penutupan DAP pada BKB. Sari Pediatri 2015;17(4):279-84. Kata kunci: duktus arteriosus persisten, bayi kurang bulan, parasetamol intravena, ibuprofen oral The Comparison of Effectiveness and Safety between Intravenous Paracetamol and Oral Ibuprofen for Persistent Ductus Arteriosus in Preterm InfantsOktaviliana Sari,* Ria Nova,* Herman Bermawi,* Erial Bahar** Background. Persistent ductus arteriosus (PDA) in preterm infants can cause hemodynamic disturbances, that it must be closed immediately. PDA can be closed using cyclooxygenase inhibitor agents (COX), mainly ibuprofen. Because the side effects, intravenous paracetamol, a peroxidase inhibitor was recently introduced as an alternative terapy for ductal closure with similar effectiveness and minimal side effects. Objectives. To compare the effectiveness and safety of intravenous paracetamol and oral ibuprofen for PDA closure in preterm infants.Methods. An open label randomized controlled study was done in seventy six preterm infants (gestational age ≤37 weeks) with echocardiographically confirmed PDA. Infant were randomly assigned to received either intravenous paracetamol or oral ibuprofen. The main outcome was the success of ductal closure and secondary outcomes were adverse effects and reopening. Results. PDA closure was achieved in 33 of 36 (91.6%) infants receiving intravenous paracetamol and in 29 of 40 (72.5%) infants receiving oral ibuprofen (p=0.03). In the ibuprofen group, thrombocytopenia and gastrointestinal bleeding were found in 28.5% and 25.7% infants respectively, while in the paracetamol group, no adverse effect was observed. There ...

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Efficacy and Safety of Oral Versus Intravenous Ibuprofen in Very Low Birth Weight Preterm Infants with Patent Ductus Arteriosus

Cited by 101 publications

References 32 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

Treatment strategy of patent ductus arteriosus in preterm infants

Perbandingan Efektifitas dan Keamanan Parasetamol Intravena dan Ibuprofen Oral pada Penutupan Duktus Arteriosus Persisten pada Bayi Kurang Bulan

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