This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Ketorolac is a drug commonly used in neonates and infants for postoperative pain. No pharmacokinetic data exists for ketorolac in these small children despite the fact that these children may be at highest risk of complications from a drug given too frequently and/or in too high a dose. Thus, this study will examine the single and multidose pharmacokinetics of ketorolac as it is used clinically in a surgical population. PHASE 1 of this study will examine ketorolac's single dose pharmacokinetics. Ketorolac (0.5mg/kg) will be administered to up to 36 subjects to achieve 24 evaluable subjects divided into two age groups (0-1 month, 1 month - 1 year). Serum specimens will then be drawn and analyzed for standard pharmacokinetic parameters. After analysis of PHASE 1 data, an appropriate dosing interval will be established for PHASE 2, a multidose pharmacokinetic trial. 36 subjects to achieve 24 evaluable subjects divided into two age groups (0-1 month, 1 month - 1 year) will be given ketorolac and have serum sampled at appropriate intervals to develop a multidose pharmacokinetic model for these subjects. The resulting data from this study will help establish appropriate dosing guidelines for ketorolac in this vulnerable population.
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