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The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Tramadol per os (Tradonal Odis® orodispersible tablets) |
|
| 2 | Active Comparator | Tramadol IV (Tradonal® IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol per os (Tradonal Odis® orodispersible tablets) | Drug | Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in pain score between groups | In the first hours after anaesthesia and surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in side-effects between the groups | In the first hours after anaesthesia and surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel Struys, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | 9000 | Belgium |
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| Label | URL |
|---|---|
| Website of the University Hospital Ghent | View source |
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| Tramadol IV (Tradonal® IV) | Drug | Administration of tramadol IV given in 3 unit dosage of 35 mg |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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