title: Comparison of the Pharmacokinetics of Ketorolac Tromethamine After Continuous Subcutaneous Infusion and Repeat Intramuscular Bolus Injections in Healthy Adult Subjects.
abstract: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that exhibits analgesic activity with no sedative or anxiolytic properties. Twelve healthy male subjects were enrolled in a study to receive either of 2 treatments over 2 periods in an open-label, randomized, 2-way crossover design: (A) 120 mg of ketorolac tromethamine administered as a continuous subcutaneous infusion over a 24-hour period; or (B) an identical total daily dose administered as 4 intramuscular bolus injections of 30 mg each given every 6 hours (current labeled treatment regimen). The pharmacokinetic and safety profiles were evaluated for both treatments. Both modes of administration have similar values for area under the curve (AUC) and half-life (t1/2), suggesting that continuous subcutaneous infusion and repeated intramuscular bolus injections have similar bioavailability. The peak plasma concentration (Cmax) was 40% lower when ketorolac was administered as a continuous subcutaneous infusion compared with repeat intramuscular bolus injections. The concentration at steady-state (Css) for continuous subcutaneous infusion was between the Cmaxand Ctroughvalues obtained following the 4 intramuscular injections. Both treatment arms were well tolerated.
authors.affiliation: SteadyMed Therapeutics, Inc., San Ramon, CA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Burdick
authors.affiliation: SteadyMed Therapeutics, Inc., San Ramon, CA, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Mamelok
authors.affiliation: SteadyMed Therapeutics, Inc., San Ramon, CA, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Hurliman
authors.affiliation: Celerion, Montreal, QC, Canada.
authors.forename: Mariève
authors.initials: M
authors.lastname: Dupuis
authors.affiliation: Celerion, Lincoln, NE, USA.
authors.forename: Yuli
authors.initials: Y
authors.lastname: Xie
authors.affiliation: Celerion, Montreal, QC, Canada.
authors.forename: Julie
authors.initials: J
authors.lastname: Grenier
authors.affiliation: Celerion, Lincoln, NE, USA.
authors.forename: Curtis
authors.initials: C
authors.lastname: Sheldon
authors.affiliation: Celerion, Lincoln, NE, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Gartner
authors.affiliation: SteadyMed Therapeutics, Inc., San Ramon, CA, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Noymer
mesh_terms: D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D019540:Area Under Curve; D018592:Cross-Over Studies; D064368:Healthy Volunteers; D006801:Humans; D055104:Infusions, Subcutaneous / Q000009:adverse effects; D007273:Injections, Intramuscular / Q000009:adverse effects; D020911:Ketorolac Tromethamine / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics*; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D020911:Ketorolac Tromethamine
keywords: NSAID; acute pain; pump