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      Treatment of Patent Ductus Arteriosus in Premature Infants: Intravenous Paracetamol or Oral Ibuprofen?

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          Abstract

          Background:

          The similarity in the mechanism of action between paracetamol and ibuprofen can cause similar side effects. However, in preterm neonates with feeding intolerance, intravenous (IV) paracetamol has replaced oral ibuprofen. Therefore, a comparison of the effectiveness and side effects is essential.

          Methods:

          In this retrospective cohort study, the data of 118 preterm infants with a definite diagnosis of patent ductus arteriosus (PDA), including 59 patients who received oral ibuprofen and 59 patients who received IV paracetamol were analyzed. Laboratory evaluations of serum total and direct bilirubin, hemoglobin, and creatinine levels before and seven days after treatment were made. Using analysis of covariance (ANCOVA) and multiple multinomial logistic regression models, the effect of two treatment groups on the post-treatment variables as well as their efficacy comparison were evaluated.

          Results:

          In both pre- and post-treatment periods, there was no significant association between echocardiography variables with treatment groups. The results from the ANCOVA model showed that the paracetamol and ibuprofen were followed by a significant decrease in the mean total bilirubin and Hct variables after treatment by 1.38 and 1.65 units, respectively. In addition, results from the Mann-Whitney U test revealed that the median Hb and K differences after and before treatment had a significant difference between the two treatment groups. Furthermore, based on the multiple multinomial logistic model results, the odds of complete arterial duct closure with IV paracetamol was 1.27 times higher than with oral ibuprofen, while in the oral ibuprofen group, the odds of closing was 1.44 times higher than the IV paracetamol group, but there was no statistically significant difference between the two groups.

          Conclusion:

          Intravenous paracetamol has equal efficacy compared to oral ibuprofen in the treatment of PDA. Also, it seems to be associated with a lower risk of hyperbilirubinemia following the treatment.

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          Acetaminophen use during pregnancy, behavioral problems, and hyperkinetic disorders.

          Zeyan Liew, Pei-Huan Lee, Jørn Olsen … (2014)
          Acetaminophen (paracetamol) is the most commonly used medication for pain and fever during pregnancy in many countries. Research data suggest that acetaminophen is a hormone disruptor, and abnormal hormonal exposures in pregnancy may influence fetal brain development. To evaluate whether prenatal exposure to acetaminophen increases the risk for developing attention-deficit/hyperactivity disorder (ADHD)-like behavioral problems or hyperkinetic disorders (HKDs) in children. We studied 64,322 live-born children and mothers enrolled in the Danish National Birth Cohort during 1996-2002. Acetaminophen use during pregnancy was assessed prospectively via 3 computer-assisted telephone interviews during pregnancy and 6 months after child birth. To ascertain outcome information we used (1) parental reports of behavioral problems in children 7 years of age using the Strengths and Difficulties Questionnaire; (2) retrieved HKD diagnoses from the Danish National Hospital Registry or the Danish Psychiatric Central Registry prior to 2011; and (3) identified ADHD prescriptions (mainly Ritalin) for children from the Danish Prescription Registry. We estimated hazard ratios for receiving an HKD diagnosis or using ADHD medications and risk ratios for behavioral problems in children after prenatal exposure to acetaminophen. More than half of all mothers reported acetaminophen use while pregnant. Children whose mothers used acetaminophen during pregnancy were at higher risk for receiving a hospital diagnosis of HKD (hazard ratio = 1.37; 95% CI, 1.19-1.59), use of ADHD medications (hazard ratio = 1.29; 95% CI, 1.15-1.44), or having ADHD-like behaviors at age 7 years (risk ratio = 1.13; 95% CI, 1.01-1.27). Stronger associations were observed with use in more than 1 trimester during pregnancy, and exposure response trends were found with increasing frequency of acetaminophen use during gestation for all outcomes (ie, HKD diagnosis, ADHD medication use, and ADHD-like behaviors; P trend < .001). Results did not appear to be confounded by maternal inflammation, infection during pregnancy, the mother's mental health problems, or other potential confounders we evaluated. Maternal acetaminophen use during pregnancy is associated with a higher risk for HKDs and ADHD-like behaviors in children. Because the exposure and outcome are frequent, these results are of public health relevance but further investigations are needed.
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            Comparison of Oral Paracetamol versus Ibuprofen in Premature Infants with Patent Ductus Arteriosus: A Randomized Controlled Trial

            Dan Dang, DONGXUAN WANG, Chuan Zhang … (2013)
            Trial Design Oral ibuprofen has demonstrated good effects on symptomatic patent ductus arteriosus (PDA) but with many contraindications and potential side-effects. In the past two years, oral paracetamol administration to several preterm infants with PDA has been reported. Here, a randomized, non-blinded, parallel-controlled and non-inferiority trial was designed to evaluate the efficacy and safety profiles of oral paracetamol to those of standard ibuprofen for PDA closure in premature infants. Methods One hundred and sixty infants (gestational age ≤34 weeks) with echocardiographically confirmed PDA were randomly assigned to receive either oral paracetamol (n = 80) or ibuprofen (n = 80). After the initial treatment course in both groups, the need for a second course was determined by echocardiographic evaluation. The main outcome was rate of ductal closure, and secondary outcomes were adverse effects and complications. Result The ductus was closed in 65 (81.2%) infants of the paracetamol group compared with 63 (78.8%) of the ibuprofen group. The 95% confidence interval of the difference between these groups was [−0.080,0.128], demonstrating that the effectiveness of paracetamol treatment was not inferior to that of ibuprofen. In fact, the incidence of hyperbilirubinemia or gastrointestinal bleeding in the paracetamol group was significantly lower than that of the ibuprofen group. No significant differences in other clinical side effects or complications were noted. Conclusion This comparison of drug efficacy and safety profiles in premature infants with PDA revealed that oral paracetamol was comparable to ibuprofen in terms of the rate of ductal closure and even showed a decreased risk of hyperbilirubinemia or gastrointestinal bleeding. Therefore, paracetamol may be accepted as a first-line drug treatment for PDA in preterm infants. Trial Registration ChiCTR.org ChiCTR-TRC-12002177
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              Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates.

              Heba El-Mahdy, Doaa El Amrousy, Marwa Elgendy … (2017)
              In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P   0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P < 0.001).
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                Author and article information

                Contributors
                Naeeme Taslimi Taleghani:
                ORCID: https://orcid.org/0000-0002-8144-2323
                Role: ConceptualizationRole: InvestigationRole: Writing – original draft
                Banafshe Hamrahi: Role: Data curationRole: Resources
                Minoo Falahi:
                ORCID: https://orcid.org/0000-0002-1346-3288
                Role: Supervision
                Eisa Nazar:
                ORCID: https://orcid.org/0000-0002-2860-6034
                Role: Formal analysis
                Farzane Palizban: Role: Visualization
                Ali Naseh: Role: Visualization
                Maryam Khoshnood Shariati:
                ORCID: https://orcid.org/0000-0003-4924-2310
                Role: Investigation
                Journal
                Journal ID (nlm-ta): Arch Iran Med
                Journal ID (iso-abbrev): Arch Iran Med
                Journal ID (publisher-id): Arch Iran Med
                Journal ID (publisher-id): AIM
                Title: Archives of Iranian medicine
                Publisher: Academy of Medical Sciences of I.R. Iran
                ISSN (Print): 1029-2977
                ISSN (Electronic): 1735-3947
                Publication date (Print): June 2023
                Publication date (Electronic): 01 June 2023
                Volume: 26
                Issue: 6
                Pages: 330-337
                Affiliations
                1Neonatal Health Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
                2Clinical Research Development Center, Mahdiyeh Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
                3Psychiatry and Behavioral Sciences Research Center, Addiction Institute, Mazandaran University of Medical Sciences, Sari, Iran
                Author notes
                [* ] Corresponding Author: Naeeme Taslimi Taleghani, Emails: naeemetaslimi@ 123456yahoo.com ; naeemetaslimi@ 123456sbmu.ac.ir
                Author information
                https://orcid.org/0000-0002-8144-2323
                https://orcid.org/0000-0002-1346-3288
                https://orcid.org/0000-0002-2860-6034
                https://orcid.org/0000-0003-4924-2310
                Article
                DOI: 10.34172/aim.2023.50
                PMC ID: 10685834
                PubMed ID: 38310434
                SO-VID: 76074f48-0f9f-4251-b480-b5b5a1928abb
                Copyright © © 2023 The Author(s).
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 22 November 2021
                Date accepted : 10 April 2022
                Categories
                Subject: Original Article

                Keywords: acetaminophen,adverse effects,ibuprofen,paracetamol,patent ductus arteriosus
                Data availability:
                Keywords: acetaminophen, adverse effects, ibuprofen, paracetamol, patent ductus arteriosus

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