Children undergoing surgery for orthapaedic, ENT, renal or abdominal conditions MedDRA version: 9.1 Level: LLT Classification code 10042609 Term: Surgery
Conditions
Interventions
Product Name: Diclofenac Sodium 50mg/5ml Oral Suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: Diclofenac
Concentration unit: mg/ml
Sponsors
Joint Sponsor: University of Glasgow with NHS greater Glasgow and Clyde
Joint Sponsor: University of Glasgow with NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 6m-12y Weight 5-50kg Undergoing elective surgery where diclofenac would routinely be used 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: 50kg Dehydration Renal impairment High risk of bleeding Receiving anticoagluants Allergy to NSAIDs Poorly controlled asthma Emergency surgery Receiving diazepam, barbiturates, rifampicin, azole antifungals and any other drugs which may induce or block the metabolic pathway related to diclofenac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine population pharmacokinetics of diclofenac in children aged 6m-12y; Secondary Objective: To determine proportion of children with each of the three genotypes relevant to metabolism of diclofenac (CYP2C8, CYP2C9 and UGT2B7) . To correlate pharmacokinetics with pharmacogenetic profile and pharmacodynamic effects. ; Primary end point(s): Population pharmacokinetics of diclofenac Pharmacogenetic subtypes for diclofenac metabolism | — |
Countries
United Kingdom
Outcome results
None listed