Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

Open-label Study of the Safety and Effectiveness of Short-term Therapy With Extended-release Tramadol (TRAMADEX-OD) in the Management of Pain After Knee Arthroscopy.

Extended-release tramadol is indicated for the management of moderate to severe pain in adults who require around-the-clock treatment. It provides an extended duration of action, more constant plasma concentrations, a reduced dosing frequency, and the potential for improved compliance and therapeutic outcomes.

The present study was designed to evaluate the safety and effectiveness of this medication in the treatment of early postoperative pain after knee arthroscopy.

Inclusion Criteria:

• Men and nonpregnant women
• Age: 18-65 years
• ASA classification I or II
• ambulatory knee arthroscopy under spinal anesthesia

Exclusion Criteria:

• Pregnancy
• Intolerance to any opioid, tramadol or paracetamol
• spine surgery in the past
• renal or hepatic impairment
• cardiac or respiratory conditions that put the patient at risk for respiratory depression
• patients receiving: monoamine oxidase inhibitors, carbamazepine, quinidine, selective serotonin reuptake inhibitors or tricyclic antidepressants