Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Acetaminophen; Tramadol

Criteria

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