Internal Medicine ·
CO-ROAM finds oliceridine non-inferior to remifentanil for ICU analgesia
In a multicentre, blinded non-inferiority trial across 19 Chinese ICUs, 304 mechanically ventilated adults received oliceridine or remifentanil. Oliceridine met the non-inferiority criterion for time in the target analgesic range and was associated with fewer reported respiratory-depression events, although the study’s selected population and setting limit generalisability.
- 304 patients analysed across 19 Chinese ICUs.
- Analgesic time in range met the non-inferiority criterion.
- Respiratory-depression events were less frequent with oliceridine.
- Ventilation duration, ICU stay and mortality did not differ.
The CO-ROAM trial randomised adults aged 18–80 years who were receiving invasive mechanical ventilation and expected to need it for more than 24 hours. The assessor- and patient-blinded study was conducted in 19 ICUs in China. Analgesics were titrated to a Critical-Care Pain Observation Tool score below 3; the primary endpoint was time in the target analgesic range, with a non-inferiority margin of −10%. The modified intention-to-treat analysis included 304 of 307 randomised patients: 151 assigned to oliceridine and 153 to remifentanil.
Median time in range was 96.0% with oliceridine and 92.3% with remifentanil, an absolute difference of 3.7% (95% CI −0.3 to 5.7%). Mild-to-moderate adverse drug reactions occurred at 15.9 versus 22.2 events per 100 patient-days (incidence rate ratio 0.72, 95% CI 0.52–1.00; P=0.049). Respiratory depression during the study period was reported in 0% versus 4.6%; post-extubation respiratory depression in 0% versus 7.9%. Mechanical-ventilation duration, ICU stay and 28-day mortality did not differ.
The findings suggest oliceridine can provide non-inferior analgesia under the trial protocol, with fewer observed respiratory events. However, the trial excluded some patients with severe organ dysfunction, hemodynamic instability or a need for deep sedation, and its findings may not generalise to all ICU populations. The study was conducted in China; subgroup findings were nominal. Oliceridine’s US commercialisation was discontinued in 2024 for business reasons, while approval status was reported unchanged.
In practice
For adults receiving invasive mechanical ventilation who resemble the CO-ROAM trial population, oliceridine provided analgesia non-inferior to remifentanil under the study protocol, with fewer observed respiratory-depression events. This is promising comparative evidence, not a basis for a general practice change: the trial was conducted in 19 Chinese ICUs and excluded patients with several serious conditions, including severe organ dysfunction, severe hemodynamic instability and need for deep sedation. Clinical outcomes including ventilation duration, ICU stay and 28-day mortality did not differ.
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Intensive Care Medicine: Efficacy and safety of oliceridine versus remifentanil for analgesia in mechanically ventilated critically ill adults (CO-ROAM): a multicenter, assessor-blinded, non-inferiority randomized controlled trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.