ICU sedation, delirium & recovery
Efficacy, safety, and pharmacokinetics of MR13A11A, a generic of remifentanil, for pain management of Japanese patients in the intensive care unit: a double-blinded, fentanyl-controlled, randomized, non-inferiority phase 3 study
Primary resultResult — go to the resultDifference 2.2% 95% CI - 0.8-5.3Authors' conclusion
Remifentanil can be used safely for pain management in mechanically ventilated Japanese patients in the ICU.
Study context
- Population
- Japanese patients aged ≥ 20 years requiring 6 h to 10 days mechanical ventilation in an intensive care unit (ICU) and requiring pain relief92 vs 90 analysed
- Participants
- 98 vs 98
- Comparison
- Remifentanil vs fentanyl continuous IV infusion
- Remifentaniln = 98
- Fentanyln = 98reference
- Primary endpoint
- Proportion of patients not requiring rescue fentanyl
Methodological detailsmulticentre, double-blinded, fentanyl-controlled, non-inferiority, phase 3
- Multicentre
- Double-blinded
- Fentanyl-controlled
- Non-inferiority
- Phase 3
Primary result
As reported in the abstract
Difference
2.2%
95% CI - 0.8-5.3
P < 0.0001
Events by treatment group
Remifentanil vs Fentanyl
difference 2.2% (95% CI - 0.8-5.3); P < 0.0001
Further findings
Pharmacokinetics (PK): blood remifentanil concentration after end of administration · 10 min
- Decreased within 10 min to almost 50% of end-of-administration level, suggesting rapid offset
- PK assessed in 24 patients
Safety
Any adverse events
Adverse drug reactions
Original publication
Efficacy, safety, and pharmacokinetics of MR13A11A, a generic of remifentanil, for pain management of Japanese patients in the intensive care unit: a double-blinded, fentanyl-controlled, randomized, non-inferiority phase 3 study. J Intensive Care. Published 13 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →