A prospective, randomized, double-blind, multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients
To compare the quality of analgesia provided by a remifentanil-based analgesia regime with that provided by a fentanyl-based regime in critically ill patients.
This was a registered, prospective, two-center, randomized, triple-blind study involving adult medical and surgical patients requiring mechanical ventilation (MV) for more than 24 h. Patients were randomized to either remifentanil infusion or a fentanyl infusion for a maximum of 30 days. Sedation was provided using propofol (and/or midazolam if required).
Primary outcome was the proportion of patients in each group maintaining a target analgesia score at all time points. Secondary outcomes included duration of MV, discharge times, and morbidity. At planned interim analysis (n = 60), 50% of remifentanil patients (n = 28) and 63% of fentanyl patients (n = 32) had maintained target analgesia scores at all time points (p = 0.44). There were no significant differences between the groups with respect to mean duration of ventilation (135 vs. 165 h, p = 0.80), duration of hospital stay, morbidity, or weaning. Interim analysis strongly suggested futility and the trial was stopped.
The use of remifentanil-based analgesia in critically ill patients was not superior regarding the achievement and maintenance of sufficient analgesia compared with fentanyl-based analgesia.
- A prospective, randomized, double-blind, multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients
Intensive Care Medicine
Volume 37, Issue 3 , pp 469-476
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- 1. Department of Anesthesiology and Intensive Care Medicine, Charité-Universitaetsmedizin Berlin, Campus Charité Mitte and Campus Virchow-Klinikum, Augustenburger Platz 1, 13353, Berlin, Germany
- 2. Departments of Anesthesiology, Intensive Care Medicine and Pain Therapy, Hospital am Eichert, Eicherstraße 3, 73035, Göppingen, Germany
- 3. SOSTANA GmbH (CRO), Wildensteiner Straße 27, 10318, Berlin, Germany