Disposition of Intravenous Ketorolac
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Ketorolac Tromethamine
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring ketorolac, pain, pregnancy, non-pregnant state
Eligibility 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
Sites / Locations
- University Hospitals Leuven
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ketorolac
Arm Description
Ketorolac will be given to all patients as a part of routine medical care
Outcomes
Primary Outcome Measures
ketorolac disposition following intravenous administration right after caesarean section
PK (concentration/time profile, protein binding, metabolism) and its covariates
Secondary Outcome Measures
optimalisation of ketorolac dose regimen during pregnancy and labor
Full Information
NCT ID
NCT01291472
First Posted
February 1, 2011
Last Updated
December 12, 2011
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01291472
Brief Title
Disposition of Intravenous Ketorolac
Official Title
Disposition of Intravenous Ketorolac After Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Prospective, single-center, open label study on the pharmacokinetics of intravenous (iv) ketorolac administration in pregnant women right after caesarean section. Patients will be included after signed informed consent. Ketorolac has been selected for this study as it is routinely administered for postoperative pain relief. At this stage, we only have the intention to document ketorolac pharmacokinetics and metabolism based on the dosing regimen as currently used in the clinical setting, and therefore will not interfere with either clinical indications, nor with dosing as prescribed by the attending physician. This drug is routinely administered (30 mg q8h) after caesarean section.
Drug administration and collection of samples will be obtained to the current clinical and nursing standard procedures. After dilution in 50-100 ml bag of normal saline drug will be administered after caesarean section 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.
Blood samples will be collected (in heparinised tubes) according to following schedule: 1, 2, 3, 4, 6 and 8 hours after iv administration, through a second peripherally inserted venous catheter dedicated for blood sampling only. Blood samples will be centrifuged immediately after collection and subsequently stored at -20 °C until analysis. Urine samples will also be collected, before drug administration in the first 8 hours after the first drug administration, through a bladder catheter in patients in whom a bladder catheter is available for clinical indications.
In a subgroup of former patients (n=8), we plan to repeat this procedure 6-12 weeks after delivery (for intra-subject PK comparison). However, only a single iv ketorolac dose will be administered, and sampling will be limited to 6 samples up to 8 h following start of iv administration. A population pharmacokinetics approach will be used, hereby comparing the data on PK already reported in adults and the newly collected data following pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
ketorolac, pain, pregnancy, non-pregnant state
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketorolac
Arm Type
Other
Arm Description
Ketorolac will be given to all patients as a part of routine medical care
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Other Intervention Name(s)
Taradyl
Intervention Description
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.
Primary Outcome Measure Information:
Title
ketorolac disposition following intravenous administration right after caesarean section
Description
PK (concentration/time profile, protein binding, metabolism) and its covariates
Time Frame
up to 8 hours after first dose administration
Secondary Outcome Measure Information:
Title
optimalisation of ketorolac dose regimen during pregnancy and labor
Time Frame
up to 8 hours after first dose administration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karel Allegaert, MD PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
23179562
Citation
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.
Results Reference
derived
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Disposition of Intravenous Ketorolac
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