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Off-label use of paracetamol in managing patent ductus arteriosus across neonatal intensive care units in the UK
  1. Arindam Mukherjee,
  2. Vishal Jadhav,
  3. Anupam Gupta
  1. Department of Neonatology, Manchester University NHS Foundation Trust, Manchester, UK
  1. Correspondence to Dr Arindam Mukherjee, St Mary's Hospital, Departmernt of Neonatology, Manchester University NHS Foundation Trust, Manchester M13 9WL, UK; arindam.mukherjee{at}

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A haemodynamically significant patent ductus arteriosus (hsPDA) contributes significantly to mortality and morbidity in infants born earlier than 28 weeks’ gestation. Intravenous ibuprofen is the only licensed medication for medical management of patent ductus arteriosus (PDA) in the UK. It has its own side effects. There is emerging evidence to suggest that paracetamol may be a safer substitute to ibuprofen.

We carried out a national telephone survey to ascertain the majority response on off-label use of paracetamol and explore areas of possible research in its use for managing hsPDA. The survey was conducted across 63 level 3 neonatal intensive care units (NICUs) in the UK between February and April 2020. A neonatal consultant was contacted in each unit. The response rate was 95% (60 of 63).

Our survey revealed that 82% (49 of 60) of NICUs in the UK use paracetamol for the management of hsPDA. While majority (65%, 32 of 49) of NICUs use paracetamol as a second-line treatment for managing hsPDA in ibuprofen-unresponsive cases, 10% (5 of 49) use paracetamol as a first-line medication in preference to ibuprofen. Of the NICUs 73% (36 of 49) use only intravenous preparation of paracetamol. Majority (51%, 25 of 49) of NICUs use paracetamol at 15 mg/kg/dose 6 hourly for 3 days, 20% (10 of 49) of NICUs use 15 mg/kg/dose 6 hourly for 5 days, and 2% (1 of 49) use 20 mg/kg/dose 6 hourly for 3 days. Respondents from the remaining NICUs were uncertain about their use of paracetamol dosage. The dosages, duration of treatment and monitoring of infants during paracetamol use remain impromptu and widely variable between the NICUs across the UK. Our telephonic interview also identified variable reports from respondents on the efficacy and the side effects of paracetamol. Of the respondents 47% (23 of 49) were unsure about the success rate of paracetamol. An overwhelming majority (57 of 60, 95%) of NICUs felt that a randomised controlled trial (RCT) is needed to evaluate the comparative efficacy of intravenous paracetamol over intravenous ibuprofen.

In summary, the medical management of PDA continues to vary significantly in different neonatal centres in the UK. Majority of level 3 NICUs in the UK are using paracetamol anecdotally to medically manage hsPDA. These findings highlight the need to establish evidence robust enough to support uniform practice recommendations in managing hsPDA. There is overwhelming interest across NICUs in the UK to participate in an RCT to compare the efficacy and safety profile of intravenous paracetamol with intravenous ibuprofen.


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  • Contributors The project was conceived by AM. AG and AM prepared the questionnaire. Data were collected by VJ and coordinated by AM. Data were analysed by AM, AG and VJ. Write-up and critical analysis were done by AM and AG. All authors read and approved the final manuscript.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; internally peer reviewed.