99 Newly approved IV acetaminophen in Canada: Should we switch from oral to IV? A systematic review
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.008 | 0.036 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.006 |
| Bibliometrics | 0.012 | 0.013 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".