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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
Original
Volume 37, Issue 3 / March , 2011

Pages 469 - 476

Abstract

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.

Keywords

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