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A prospective, randomized, double-blind, multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients.

Author(s): Spies C, Macguill M, Heymann A, Ganea C, Krahne D, Assman A, Kosiek HR, Scholtz K, Wernecke KD, Martin J

Affiliation(s): Department of Anesthesiology and Intensive Care Medicine, Charite-Universitaetsmedizin Berlin, Campus Charite Mitte and Campus Virchow-Klinikum, Berlin, Germany. claudia.spies@charite.de

Publication date & source: 2011-03, Intensive Care Med., 37(3):469-76. Epub 2010 Dec 17.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

Page last updated: 2011-12-09

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