A Prospective, Randomized, Double-Blind, Multicenter Study Comparing Remifentanil with Fentanyl in Mechanically Ventilated Patients

Claudia Spies, Martin MacGuill, Anja Heymann, Christina Ganea, Daniel Krahne, Angelika Assman, Heinrich-Rudolf Kosiek, Kathrin Scholtz, Klaus-Dieter Wernecke, Jörg Martin

Intensive Care Med (2011) 37 

Purpose: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

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