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Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months

Anne M Lynn1, Heidi Bradford, Eric D Kantor

  • 1Department of Anesthesia & Pain Management, Seattle Children's Hospital, Seattle, WA 98105, USA. anne.lynn@seattlechildrens.org

Paediatric Anaesthesia
|January 5, 2011
PubMed

Insights

Ketorolac

Area of Science:

  • Pharmacology and Therapeutics
  • Pediatric Anesthesiology

Background:

  • Limited data exists on ketorolac pharmacokinetics in infants.
  • Previous studies suggest potential utility of ketorolac in pediatric pain management.

Purpose of the Study:

  • To determine the postoperative pharmacokinetics (PK), safety, and analgesic effects of ketorolac in infants younger than 6 months.
  • To evaluate the stereo-isomer-specific clearance of ketorolac in this age group.

Main Methods:

  • A double-blinded, placebo-controlled study involving 14 infants (<6 months) postoperatively.
  • Randomized administration of placebo, 0.5 mg·kg(-1), or 1 mg·kg(-1) ketorolac intravenously (IV).
  • Pharmacokinetic analysis using noncompartmental and population modeling, integrating data with previously studied infants and toddlers.

Main Results:

  • A two-compartmental model described the combined data. Population estimates for R (+) and S (-) isomers' clearance and volume of distribution were determined.
  • Elimination half-lives were 191 minutes for the R (+) isomer and 33 minutes for the S (-) isomer.
  • No significant changes in renal/hepatic function, surgical output, or oxygen saturation were observed. Morphine use was similar across groups.

Conclusions:

  • Stereo-isomer-specific clearance in infants (2-6 months) demonstrates rapid elimination of the analgesic S (-) isomer, consistent with older infants.
  • Single IV doses of ketorolac were found to be safe in this pediatric population, with no observed adverse effects.
Abstract

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