Efficacy and safety of oral paracetamol versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants: a randomized controlled trial

El-Farrash, Rania A.; Shimy, Mohammed S El; El-Sakka, Abeer S; Ahmed, Manal G; Abdel-Moez, Dina G

doi:10.1080/14767058.2018.1470235

Cited by 32 publications

(45 citation statements)

References 22 publications

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“…There were a total of 1547 subjects from 10 studies. 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 The studies enrolled neonates ≤28 weeks (1 study), ≤30 weeks (2 studies), ≤32 weeks (2 studies), ≤34 weeks (2 studies), and ≤37 weeks (3 studies) of gestational age. Birthweights varied across studies.…”

Section: Resultsmentioning

confidence: 99%

The efficacy and safety of oral paracetamol versus oral ibuprofen for patent ductus arteriosus closure in preterm neonates – A systematic review and meta-analysis

Pranata

Yonas

Vania

et al. 2020

Indian Heart Journal

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Objective This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of oral acetaminophen compared to oral ibuprofen for patent ductus arteriosus (PDA) in preterm infants. Methods We performed a systematic literature search on topics that assesses the use of oral paracetamol compared to oral ibuprofen in preterm neonates diagnosed with PDA from PubMed, EuropePMC, Cochrane Central Database, ScienceDirect, ProQuest, ClinicalTrials.gov, and hand-sampling from potential articles. Results There were 1547 subjects from 10 selected studies. Primary closure rate was similar in both groups. Subgroup analysis on studies enrolling neonates with ≤30 weeks gestational age showed that ibuprofen was superior (OR 0.52 [0.31, 0.90], I 2 : 0%). On the other hand, paracetamol was superior neonates with ≤34 weeks gestational age (OR 1.73 [1.01, 2.94], I 2 : 30%). Reopening rate, surgical closure rate, mortality, intraventricular hemorrhage, and necrotizing enterocolitis were similar in both groups. Rate of renal dysfunction (OR 0.27 [0.10, 0.77], I 2 : 0%) and gastrointestinal bleeding (OR 0.31 [0.11, 0.88], I 2 : 0%) were lower in paracetamol group. Subgroup analysis of randomized controlled studies (RCTs) showed similar results. Meta-regression analysis showed that the primary closure rate was not influenced by gestational age, birth weight, and gender. GRADE demonstrates a low level of certainty for primary closure and mortality. Renal dysfunction and gastrointestinal bleeding havea moderate level of certainty. Conclusion There was no significant difference between the efficacy of oral paracetamol and oral ibuprofen. However, the rate of renal dysfunction and gastrointestinal bleeding were higher in oral ibuprofen.

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Section: Resultsmentioning

confidence: 99%

The efficacy and safety of oral paracetamol versus oral ibuprofen for patent ductus arteriosus closure in preterm neonates – A systematic review and meta-analysis

Pranata

Yonas

Vania

et al. 2020

Indian Heart Journal

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“…In the second search, of 13 systematic reviews and 59 citations retrieved, three systematic reviews (33)(34)(35) were assessed to extract RCTs or quasi-RCTs ( Table 3). Seven records (38)(39)(40)(41)(42)(43)(44) containing six trials met our inclusion criteria. Therefore, by summarizing the trials of the first and second searches, 15 trials were eventually included in our review ( Table 4).…”

Section: Description Of Studiesmentioning

confidence: 99%

Efficacy and Safety of Paracetamol for Patent Ductus Arteriosus Closure in Preterm Infants: An Updated Systematic Review and Meta-Analysis

Xiao

Liu

et al. 2020

Front. Pediatr.

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“…Paracetamol is considered an atypical cyclooxygenase inhibitor with analgesic and antipyretic effects, but without anti‐inflammatory properties. Interestingly, paracetamol seems equally effective as NSAIDs such as indomethacin or ibuprofen in the treatment of PDA in preterm infants . This led to the fear that paracetamol might have similar effects prenatally.…”

Section: Discussionmentioning

confidence: 99%

“…Recent publications have raised the question of an association between third‐trimester paracetamol use and ductus arteriosus constriction in the fetus, however . Furthermore, paracetamol has been shown to be as effective as NSAIDs in the treatment of patent ductus arteriosus Botalli in newborns . These observations have supported concerns about whether paracetamol can still be recommended as a safe treatment option during the third trimester.…”

Section: Introductionmentioning

confidence: 99%

Negligible risk of prenatal ductus arteriosus closure or fetal renal impairment after third‐trimester paracetamol use: evaluation of the German Embryotox cohort

Dathe

Frank

Padberg

et al. 2019

BJOG

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A recent case series evaluated a potential link between paracetamol use during pregnancy and premature constriction or closure of the fetal ductus arteriosus (Allegaert et al. Br J Clin Pharmacol 2019;85:245-51). Criteria from the World Health Organization Uppsala Monitoring Centre causality assessment tool were applied, and in 15 of 25 cases, causality was classified as probable or certain, with another nine cases classified as possible. How should this information be interpreted clinically given that there are no denominators and attributable risk cannot be determined? Ultimately, what providers and patients want to know is, what amount of risk, if any, is present. Given how common paracetamol use is in pregnancy (Werler et al. Am J Obstet Gynecol. 2005;193(3,pt 1):771-7) and how rare premature closure of the fetal ductus arteriosus is (Enzensberger et al. 2012;31:1285-91), risk, if present, is likely extraordinarily low. Another important consideration is that it is possible that with tens of millions of exposures there could be a handful of clinical scenarios which, by pure chance, could have demonstrated clinical findings suggestive of an association between paracetamol exposure and the outcome.While these broad inferences from cross-sectional epidemiology provide reassurance, the study by Dathe et al. (BJOG 2019;126:1560-7) provides more focused evidence. Dathe et al. performed a cohort analysis with prospectively enrolled patients comparing first and second trimester paracetamol exposure to third trimester exposure. Evaluating 604 women with third trimester exposure and 1192 women with first and second trimester exposure, no increased risk was seen for a broad range of fetal and neonatal outcomes. Compared with other analgesia options including NSAIDs and opioids, these findings support the continued use of paracetamol as a first-line agent in pregnancy.Although the evidence from the current trial should be reassuring for patients and clinicians, future research is indicated. It is possible that there is a non-negligible risk for specific subpopulations including women who received relatively high doses of acetaminophen for prolonged periods during the third trimester. The case series by Allegart et al. included several women taking a much greater cumulative dose of acetaminophen than is typical during pregnancy. That acetaminophen is available over the counter precludes some study approaches; for example, examining payer data for pharmacy receipts and outcomes. Given the known risks of alternative drugs such as NSAIDs in the third trimester of pregnancy, this article adds support to the present recommendation that paracetamol should be the primary therapy for fever and pain during this gestational period. However, there remain limitations in our knowledge and therefore large or prolonged doses should be avoided if possible.

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Efficacy and safety of oral paracetamol versus oral ibuprofen for closure of patent ductus arteriosus in preterm infants: a randomized controlled trial

Abstract: Oral paracetamol is an effective and well-tolerated first-line drug treatment for PDA in premature infants.

Cited by 32 publications

References 22 publications

The efficacy and safety of oral paracetamol versus oral ibuprofen for patent ductus arteriosus closure in preterm neonates – A systematic review and meta-analysis

The efficacy and safety of oral paracetamol versus oral ibuprofen for patent ductus arteriosus closure in preterm neonates – A systematic review and meta-analysis

Efficacy and Safety of Paracetamol for Patent Ductus Arteriosus Closure in Preterm Infants: An Updated Systematic Review and Meta-Analysis

Negligible risk of prenatal ductus arteriosus closure or fetal renal impairment after third‐trimester paracetamol use: evaluation of the German Embryotox cohort

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