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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadex-OD | Active Comparator | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended-release tramadol | Drug | 30 minutes prior vto surgery and 24 hours afterwards, patients will take a tablet of 100 mg TRAMADEX-OD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and effectiveness of TRAMADEX-OD will be evaluated by recording adverse events and using a visual analogue score for pain evaluation | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction will be evaluated by a telephone interview | up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaacov Gozal, MD | Contact | 972-2-6555614 | gozaly@szmc.org.il | |
| Anna Lev, MD | Contact | 972-2-6555104 | anamlev@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaacov Gozal, MD | Shaare Zedek Medical center, Jerusalem, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| paracetamol | Drug | in the control group, postoperative pain will managed with 1 gr paracetamol (per os) as needed (up to 4 times a day) |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |