Safety and Effectiveness of Tramadex-OD After Knee Arthroscopy
NCT ID: NCT01024348
Last Updated: 2010-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-12-31
2011-12-31
Brief Summary
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The present study was designed to evaluate the safety and effectiveness of this medication in the treatment of early postoperative pain after knee arthroscopy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
extended-release tramadol
30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
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.
paracetamol
in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)
Interventions
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extended-release tramadol
30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD
paracetamol
in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 18-65 years
* ASA classification I or II
* ambulatory knee arthroscopy under spinal anesthesia
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Shaare Zedek Medical Center, Jerusalem, Israel
Principal Investigators
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Yaacov Gozal, MD
Role: PRINCIPAL_INVESTIGATOR
Shaare Zedek Medical center, Jerusalem, Israel
Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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gozal123456
Identifier Type: -
Identifier Source: org_study_id
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