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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
History of Changes
  Purpose

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.


Condition Intervention
Postoperative Pain
 Drug: extended-release tramadol
Drug: paracetamol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Patient satisfaction will be evaluated by a telephone interview [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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.
 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024348

Contacts
Contact: Yaacov Gozal, MD 972-2-6555614 gozaly@szmc.org.il
Contact: Anna Lev, MD 972-2-6555104 anamlev@gmail.com

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: Yaacov Gozal, MD     972-2-6555614     gozaly@szmc.org.il    
Principal Investigator: Yaacov Gozal, MD            
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical center, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Yaacov Gozal, MD, Shaare Zedek Medical Center, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01024348     History of Changes
Other Study ID Numbers: gozal123456
Study First Received: October 13, 2009
Last Updated: February 1, 2010
Health Authority: Israel: Ethics Commission

Keywords provided by Shaare Zedek Medical Center:
Surgery, knee arthroscopy
Pain, postoperative
tramadol, extended release

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Acetaminophen
Tramadol
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 16, 2013