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Tapentadol vs Pregabalin for Post-operative Pain After TKA
NCT03604354Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2018
- Primary completion
- Mar 2020
- Countries
- 1
- Sponsor
- AIIMS New Delhi
- Modality
- Small Molecules
- Drugs
- tapentadol
- Conditions
- postoperative pain
01
Overview
Phase 4, randomised, double-blind trial of tapentadol in postoperative pain (2 arms), sponsored by AIIMS New Delhi. Primary endpoint: Visual Analogue Scale at 24 hours. Started Aug 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tapentadol Arm
Tapentadol 100 mg oral tablet.
Pregabalin Arm
Pregabalin 150 mg oral tablet.
03
Who it enrols
Patients aged 18-75 years undergoing unilateral total knee arthroplasty, excluding those with respiratory diseases, epilepsy, neurological disorders, renal/liver disease, or recent use of MAOIs and gabapentinoids.
04
Endpoints
Primary
Visual Analogue Scale
Secondary
Total Pain Relief
Total Rescue Analgesic Consumption
Treatment Emergent Adverse Events
Percentage of Adverse Events in a 4-point Verbal Scale
Cyclo-oxygenase-2
Reduction of VAS and nausea/vomiting
Time to 1st patient request for supplemental analgesia
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