NCT01024348

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shaare Zedek Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	extended-release tramadol	30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
DRUG	paracetamol	in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2009-12-02
• Last updated: 2010-02-02

Locations

1 site across 1 country: Israel