ISRCTN37500282
Completed
Phase 4
The cerebrospinal fluid (CSF) pharmacokinetics of a single pre-operative intravenous bolus dose of diclofenac (Dyloject®) in comparison to diclofenac infusion (Voltarol®): a prospective open-label randomised single-centre phase IV study
Barts and The London NHS Trust (UK)0 sites20 target enrollmentFebruary 12, 2009
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Peri-operative anti-inflammatory analgesia
- Sponsor
- Barts and The London NHS Trust (UK)
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients aged at least 18 years
- •2\. Scheduled to undergo surgery performed under spinal anaesthesia
- •3\. Patients must be inpatients
- •4\. Patient has given written informed consent
Exclusion Criteria
- •1\. History of bleeding diathesis or use of anticoagulant or antiplatelet agent
- •2\. History of spinal or neurological disease (including raised intracranial pressure), or surgery contraindicating spinal anaesthesia
- •3\. Use of aspirin within 72 hours prior to surgery
- •4\. Use of other non\-steroidal anti\-inflammatory drugs (NSAIDs), paracetamol or steroids within 12 hours before surgery
- •5\. Hypersensitivity to diclofenac or local anaesthetics
- •6\. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) or blood urea nitrogen (BUN) greater than 1\.5 x the upper limit of the reference range, or creatinine greater than the upper limit of the reference range
- •7\. Any other abnormal laboratory results considered clinically significant in relation to this study by the investigator
- •8\. Presence of oliguria, anaemia, hypotension or hypovolaemia
- •9\. Contraindications to NSAID/diclofenac
- •10\. Patients who are unwilling or unable to conform to the protocol
Outcomes
Primary Outcomes
Not specified
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