The pharmacokinetics of single and multiple doses of intravenous ketorolac in children - Pharmacokinetics of I.V Ketorolac in Childre
- Conditions
- There is no medical condition being investigated. This is a pharmacokinetic study to be performed in children routinely treated with ketorolac for post surgical pain in line with local treatment protocols.
- Registration Number
- EUCTR2009-012512-41-GB
- Lead Sponsor
- HS Grampian
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Children under 16 years of age administered intravenous ketorolac for routine post-operative pain relief following elective surgery, according to local treatment protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients will be excluded from the study for:
1: The anaesthetist does not anticipate that the child will require post surgical
ketorolac;
2: Routine evidence of liver dysfunction;
3: Routine evidence of renal impairment;
4: Known hypersensitivity to ketorolac or any of the components of the intravenous
formulation of ketorolac;
5: Prior use of ketorolac within 24 hours of the study; and
6: Parental or child objection to the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this research is to assess how the age, weight, height and body surface area of a child affects the metabolism and excretion of intravenous ketorolac given to relieve post-operative pain.;Secondary Objective: ;Primary end point(s): Blood Ketorolac enantiomer concentration with time.
- Secondary Outcome Measures
Name Time Method