Oral acetaminophen and postoperative delirium in noncardiac surgical older patients requiring intensive care unit admission: A pragmatic randomized controlled trial

Analgesic strategies sparing opioids may reduce the incidence of postoperative delirium (POD), a grave complication affecting primarily older surgical patients. The effect of oral acetaminophen on POD in noncardiac surgical older patients requiring intensive care unit (ICU) admission is unknown. This single-center, pragmatic, open-label, parallel randomized controlled trial conducted in the ICU of Xiangya Hospital, from February 2019 to April 2021 evaluated the effect of oral acetaminophen vs. intravenous sufentanil on POD in noncardiac surgical patients aged ≥65 years. Patients in the acetaminophen group received oral acetaminophen, 500 mg, every 8 h, for the first 48 h after ICU admission, while patients in the sufentanil group received intravenous sufentanil 3.0 μg/h, throughout the first 48 h after ICU admission. The primary outcome was POD on postoperative days 1–5 by the confusion assessment method. The secondary outcomes included pain score, ICU and hospital stay, 28-day mortality, gastrointestinal complications, quality of life, and cognitive function by telephone interview for cognitive status modified questionnaire. A total of 164 patients, median aged 74.8 (IQR: 62–91) years, participated in this study. POD occurred in 9 out of 82 patients (11.0 %) in the acetaminophen group and 14 out of 82 patients (17.1 %) in the sufentanil group. Oral acetaminophen did not lead to a reduced POD risk (risk ratio = 0.6; 95 % CI: 0.3 to 1.4; P = 0.262). There was no between-group difference in the distribution of the accumulated POD incidence throughout postoperative days 1–5 (log-rank P = 0.270). There were no between-group differences among the secondary outcome measures. Oral acetaminophen administered during the initial 48 h after ICU admission did not lead to a reduced incidence of POD compared with intravenous sufentanil treatments in older noncardiac surgical patients. Trail Registration ClinicalTrials.gov Identifier: NCT03763084.