The unlicensed and off-label use of diclofenac in paediatric patients: Pharmacokinetic, pharmacodynamic and pharmacogenomic evlauations - Diclofenac in Paediatrics
Phase 1
- Conditions
- Children undergoing surgery for orthapaedic, ENT, renal or abdominal conditionsMedDRA version: 9.1 Level: LLT Classification code 10042609 Term: Surgery
- Registration Number
- EUCTR2005-005124-14-GB
- Lead Sponsor
- Joint Sponsor: University of Glasgow with NHS greater Glasgow and Clyde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
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
<6m
<5kg
>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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method