Interventional cohort study of prolonged use (>72 hours) of paracetamol in neonates: protocol of the PARASHUTE study.

ABSTRACT:

Introduction

Anticipated or actual pain in neonates results in use of paracetamol for prolonged pain relief in many neonatal intensive care units. Clinical trials examining safety of paracetamol exposure in neonates have been of short duration (1-3 days) and hepatic biomarkers and paracetamol metabolism are rarely reported in the same studies.We aim to investigate the safety (hepatic tolerance) and effectiveness of prolonged paracetamol exposure in neonates by measuring hepatic biomarkers, plasma concentrations of paracetamol and its metabolites and pain scores. In addition, we study a possible interaction between ethanol and paracetamol.

Methods and analysis

A multicentre interventional cohort study.Neonates of any gestational age and up to 44 weeks postmenstrual age, treat

SUBMITTER: Haslund-Krog SS 

PROVIDER: S-EPMC6542439 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature