drugset / Trial / NCT01291472

Disposition of Intravenous Ketorolac

NCT01291472

Phase 4 Completed 42 enrolled Universitaire Ziekenhuizen KU Leuven
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is: * to document ketorolac disposition (concentration/time profile, protein binding, metabolism) and its covariates following intravenous (iv) administration of ketorolac right after caesarean section and to compare those observations (n=32) with non-pregnant state (n=8) (intra-subject PK comparison) * to document biochemical tolerance of ketorolac * to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are appropriated and needed * to quantify the neonatal exposure to ketorolac through excretion in the breast milk

Timeline

Start
2011-06
Primary completion
2011-09
Completion
2011-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketorolac Other / unclassified 30 mg Intravenous

Indications

No indication recorded.