Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01024348
First received: October 13, 2009
Last updated: February 1, 2010
Last verified: February 2010

October 13, 2009
February 1, 2010
December 2009
December 2010   (final data collection date for primary outcome measure)
Safety and effectiveness of TRAMADEX-OD will be evaluated by recording adverse events and using a visual analogue score for pain evaluation [ Time Frame: up to 48 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01024348 on ClinicalTrials.gov Archive Site
Patient satisfaction will be evaluated by a telephone interview [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Postoperative Pain
  • Drug: extended-release tramadol
    30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
    Other Names:
    • Tramadol
    • Tramal
  • Drug: paracetamol
    in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)
    Other Names:
    • Acamol
    • Acetominophen
  • Active Comparator: Tramadex-OD
    Patients will undergo knee arthroscopy under spinal anesthesia without any opioid. 30 minutes prior to surgery and 24 hours afterwards, patients will take a tablet of 100 mg Tramadex-OD. Breakthrough pain will be managed with 1 gr paracetamol (per os) as needed.
    Intervention: Drug: extended-release tramadol
  • Active Comparator: Control group
    Patients will undergo knee arthroscopy under spinal anesthesia without any opioid.Postoperative pain will be managed throughout the study with 1 gr paracetamol (per os) every 6 hours as required.
    Intervention: Drug: paracetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Yaacov Gozal, MD 972-2-6555614 gozaly@szmc.org.il
Contact: Anna Lev, MD 972-2-6555104 anamlev@gmail.com
Israel
 
NCT01024348
gozal123456
Yes
Yaacov Gozal, MD, Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical center, Jerusalem, Israel
Shaare Zedek Medical Center
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP