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.
Conditions
Interventions
Trade Name: Toradol (10mg/ml)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ketorolac trometamol
CAS Number: 74103-07-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentrati
Sponsors
NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed