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Randomized Controlled Trial Comparative Study Clinical Trial
Pharmacokinetics of intranasal alfentanil.
- R Schwagmeier, N Boerger, W Meissner, and H W Striebel.
- Department of Anesthesiology and Intensive Care Medicine, Benjamin Franklin Medical Center, Free University of Berlin, Germany.
- J Clin Anesth. 1995 Mar 1; 7 (2): 109-13.
Study ObjectiveTo determine the pharmacokinetics of intranasal and intravenous (IV) administrations of alfentanil in 10 healthy volunteers.DesignRandomized, prospective, double-blind, placebo-controlled, cross-over trial with at least one week between the two modes of administration.SettingHealthy volunteers at a university medical center.Subjects10 healthy, nondrug-dependent volunteers.InterventionsAlfentanil 0.54 mg was administered either intranasally [with 12 ml of sodium chloride (NaCl) 0.9% IV] or IV (with 12 sprays of NaCl 0.9% intranasally). Each subject was assigned once to the intranasal and once to the IV group. To guarantee a complete elimination of alfentanil, there was a time period of at least one week between the different modes of administration.Measurements And Main ResultsVenous blood was sampled from a cubital vein at 3, 6, 9, 12, 15, 20, 30, 60, and 120 minutes after administration. Alfentanil plasma concentrations were determined by radioimmunoassay. Maximal plasma concentrations were 20.1 ng/ml +/- 7.3 ng/ml after 9 minutes in the intranasal group. At this measurement point, the intranasal alfentanil concentrations were 64.7% (18.7 ng/ml +/- 6.8 ng/ml) of the IV concentrations (28.9 ng/ml +/- 7.9 ng/ml). The calculated bioavailability after intranasal administration was 64.96% +/- 26.3%.ConclusionsThis pharmacokinetic study demonstrates a rapid rise in plasma concentrations, as well as a high bioavailability, following the intranasal administration of alfentanil.
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