Measurement of the blood levels of the painkiller diclofenac in children following a single intravenous dose
Phase 4
Completed
- Conditions
- Pharmacokinetic study in childrenSurgery
- Registration Number
- ISRCTN65890744
- Lead Sponsor
- Central Manchester Foundation Trust (CMFT) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Children aged 2 to 8 years undergoing routine surgery including ear, nose and throat (ENT), orthopaedic, urological and general
Exclusion Criteria
1. Previous allergic reaction to nonsteriodal anti-inflammatory drugs (NSAIDs)
2. Known bleeding tendency
3. Administration of a NSAID within the past 24 hours
4. History of liver disease, abnormal renal function and gastrointestinal bleeding
5. Children with special needs in view of consent issues
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma diclofenac assays
- Secondary Outcome Measures
Name Time Method Measuring decaying plasma concentrations to estimate ancillary parameters such as Cmax, Tmax, UAC and T1/2