99 Newly approved IV acetaminophen in Canada: Should we switch from oral to IV? A systematic review

Abstract Background Acetaminophen is the most commonly used drug in children. In 2019, an IV formulation became available in Canada, but with a price tag >500 times higher than oral acetaminophen. Acetaminophen use has been growing in the US since its approval in 2011, leading to a significant health cost increase. Therefore, strict criteria for IV acetaminophen administration are needed to guide clinicians with a rational choice for route of administration and contain costs. Objectives To undertake a systematic review of available evidence comparing oral versus IV acetaminophen use in children. Design/Methods A systematic literature search was conducted on 5 databases until October 2019. All prospective interventional studies comparing IV to oral acetaminophen in patients <18 years old were included. Study selection, data collection and analysis were done according to PRISMA guidelines. Results Among 6417 abstracts, 29 full text articles were assessed, of which only 3 were retained. Indication for acetaminophen use in these studies was: analgesia (2 studies) and fever (1 study). Studies focused on: - Pharmacokinetics: In 2019, the first determination of oral bioavailability (F) of acetaminophen in children was reported in 47 stable PICU patients (microtracer study design with a population pharmacokinetic study). It showed an F=72% with a high inter-individual variability (range: 11%-91%). - Pharmacodynamics studies: • Analgesia: Analgesic efficacy after cleft palate repair was compared in 45 children (median age: 8 month) divided in three arms receiving either oral (15mg/kg every 6h), IV (12.5mg/kg every 6h) or placebo in a double-blind randomized controlled trial. No difference in pain scores and opioids requirements was found between the oral and IV acetaminophen groups. • Fever: An open-label prospective observational study reported the effect of IV (15mg/kg) versus oral acetaminophen (15mg/kg) on the evolution of temperature in children with fever >39.5°C in hospital and outpatient settings. Two hundred patients (mean age 6.7 years) were included in each arm. Temperature decreased quicker with IV administration but 4 hours after administration, temperature was similar in each group. Conclusion Despite the widespread use of IV acetaminophen, there is little evidence to suggest that it improves analgesia compared to the oral formulation. Similarly, fever weans faster but whether this translates into any meaningful clinical outcome is unknown. Available data is insufficient to guide clinicians with a rational choice of route of administration, but the significantly higher costs do not seem justified by the small (if any) benefits of IV vs oral acetaminophen.

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