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Acetaminophen for fever did not affect ICU stays in critically ill patients

Early receipt of acetaminophen as a treatment for fever did not reduce ICU stays or mortality in patients who had probable infections, according to data recently published in The New England Journal of Medicine.

Paul Young, MD, Wellington Regional Hospital, New Zealand, and colleagues conducted a binational, masked, randomized, controlled trial to investigate the effects of acetaminophen.

The researchers enrolled patients from 23 ICUs in Australia and New Zealand. Patients were aged 16 years and older with a temperature of at least 100.4° F and a probable infection. The final intent-to-treat population consisted of 690 patients; 346 patients were assigned to IV acetaminophen (Perfalgan, Bristol-Myers Squibb) and 344 were assigned to placebo, 5% dextrose in water, every 6 hours.

Young and colleagues stated that acetaminophen and placebo were administered "until 28 days after enrollment or the occurrence of one of the prespecified cessation criteria: discharge from the ICU, resolution of fever as defined by a prespecified algorithm, cessation of antimicrobial therapy, death or the development of a contraindication to the study drug."

Results showed that, within the first 28 days, there was no significant difference in ICU-free days between patients who received acetaminophen and patients who received the placebo (absolute difference = 0 days; 96.2% CI, 0-1; P = .07). Patients in the acetaminophen group had 23 ICU-free days (interquartile range 13-25 days) and patients in the placebo group had 22 ICU-free days (interquartile range 12 to 25 days).

"Early administration of acetaminophen to treat fever due to probable infection did not affect the number of ICU-free days," Young and colleagues wrote. "There was no significant between-group difference in 28-day mortality, 90-day mortality or survival time to day 90."

The researchers reported that 48 patients who received acetaminophen and 47 patients who received placebo died by day 28 (relative risk = 1.02; 95% CI, 0.68-1.52; P = .94). Additionally, 55 patients who received acetaminophen and 57 patients who received placebo died by day 90 (relative risk = 0.96; 95% CI, 0.66-1.39; P = .84).

Young and colleagues also noted that patients who received acetaminophen did not experience significantly more adverse events. They stated 28 patients who received acetaminophen and 34 placebo patients discontinued treatment due to liver dysfunction (OR = 0.89; 95% CI, 0.69-1.16; P = .4). – by Chelsea Frajerman Pardes

Disclosures: Young reports grant support from the Health Research Council of New Zealand, the Waikato Medical Research Foundation, and the Australian and New Zealand Intensive Care Foundation during the conduct of the study. Please see the full study for a list of all other authors' relevant financial disclosures.