There is no medical condition to be investigated. This is a pharmacokinetic study to be performed in children routinely treated with intravenous paracetamol for post surgical pain in line with local treatment protocol.
Conditions
Interventions
Trade Name: Perfalgan
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paracetamol
CAS Number: 103-90-2
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conce
Sponsors
NHS Grampian Research and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children under 16 years of age administered intravenous paracetamol 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 anaethetist does not anticipate that the child will require post surgical intravenous paracetamol; 2: Routine evidence of liver dysfunction; 3: Routine evidence of renal impairment; 4: Known hypersensitivity to paracetamol or any of the components of the intravenous formulation of paracetamol: 5: Prior use of paracetamol within 24 hours of the study; and 6: Parental or child objection to study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): Blood paracetamol concentration with time;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 an excretion of intravenous paracetamol given to relieve post-operative pain. | — |
Countries
United Kingdom
Outcome results
None listed