Disposition of Intravenous Ketorolac
2 other identifiers
interventional
42
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 postoperative-pain
Started Jun 2011
Shorter than P25 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 8, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 13, 2011
February 1, 2011
3 months
February 1, 2011
December 12, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ketorolac disposition following intravenous administration right after caesarean section
PK (concentration/time profile, protein binding, metabolism) and its covariates
up to 8 hours after first dose administration
Secondary Outcomes (1)
optimalisation of ketorolac dose regimen during pregnancy and labor
up to 8 hours after first dose administration
Study Arms (1)
ketorolac
OTHERKetorolac will be given to all patients as a part of routine medical care
Interventions
After dilution (solution for injection, 10 mg/1ml) in 50-100 ml bag of normal saline drug will be administered by iv bolus, through a peripherally inserted venous catheter, 30 mg, 3 times in one day. The intended duration of administration is 5-10 minutes.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- withdrawal of informed written consent
- known NSAID's intolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
Related Publications (1)
Kulo A, Hendrickx S, de Hoon J, Mulabegovic N, van Calsteren K, Verbesselt R, Allegaert K. The impact of pregnancy on urinary ketorolac metabolites after single intravenous bolus. Eur J Drug Metab Pharmacokinet. 2013 Mar;38(1):1-4. doi: 10.1007/s13318-012-0108-7. Epub 2012 Nov 21.
PMID: 23179562DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karel Allegaert, MD PhD
Universitaire Ziekenhuizen KU Leuven
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2011
First Posted
February 8, 2011
Study Start
June 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
December 13, 2011
Record last verified: 2011-02