Disposition of Intravenous Ketorolac

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• signed informed written consent

• pregnant women to whom ketorolac is administered by intravenous route for clinical indications

• preferable availability for revision in 6-12 weeks after delivery (around routine post-delivery check-up).

Exclusion Criteria:

• withdrawal of informed written consent

• known NSAID's intolerance