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Disposition of Intravenous Ketorolac

NCT01291472 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-12-13

No results posted yet for this study

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

Conditions

  • Postoperative Pain

Interventions

DRUG

Ketorolac Tromethamine

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.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Karel Allegaert, MD PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291472 on ClinicalTrials.gov