• Anesthesia and analgesia · Oct 2011

    Randomized Controlled Trial Comparative Study

    Propofol in a modified cyclodextrin formulation: first human study of dose-response with emphasis on injection pain.

    • Crystal B Wallentine, Noriko Shimode, Talmage D Egan, and Nathan L Pace.
    • Department of Anesthesiology, University of Utah, Salt Lake City, UT, USA.
    • Anesth. Analg.. 2011 Oct 1;113(4):738-41.

    BackgroundA new lipid-free preparation of propofol has been developed containing the drug, sulfobutylether ß-cyclodextrin and water. The primary objective of this study was to compare the effects of propofol in the lipid formulation with those of the new cyclodextrin formulation, particularly with regard to pain on injection. We hypothesized that the propofol in cyclodextrin would be associated with less pain on injection than propofol in lipid.MethodsThe study was a single-center, double-blind, 2-period, randomized, dose-escalating study using a completely balanced cross-over design in healthy volunteers. Pain on injection was compared between propofol in cyclodextrin and propofol in lipid using subject and observer assessments of pain rated at several different time points. Five response variables to pain were analyzed.ResultsPropofol in cyclodextrin had significantly higher pain scores for all 5 variables. Other endpoints, including sedation, showed no difference.ConclusionThe propofol in cyclodextrin formulation failed to reduce the pain on injection associated with propofol.

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