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Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol).
Comparison of two different regimens of analgesia after inguinal hernia repair. First, is a classical intravenous protocol with paracetamol and tramadol. This is the classical approach. Second is an oral protocol with Zaldiar (combination of paracetamol and tramadol). This is the new approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Z | Experimental | Postoperative Analgesia with Zaldiar |
|
| Group PT | Active Comparator | Postoperative Analgesia with Paracetamol-Tramadol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zaldiar | Drug | Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Pain | Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale. | In recovery room |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Deflandre | Astes | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Z | Postoperative Analgesia with Zaldiar Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol) |
| FG001 | Group PT | Postoperative Analgesia with Paracetamol-Tramadol Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Z | Postoperative Analgesia with Zaldiar Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol) |
| BG001 | Group PT | Postoperative Analgesia with Paracetamol-Tramadol Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Pain | Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale. | Posted | Median | Standard Deviation | units on a scale | In recovery room |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Z | Postoperative Analgesia with Zaldiar Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. DEFLANDRE Eric | ASTES | 0032477764241 | eric.deflandre@gmail.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Paracetamol-Tramadol | Drug | Postoperative analgesia with intravenous Paracetamol and Tramadol |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Group PT | Postoperative Analgesia with Paracetamol-Tramadol Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol | 0 | 27 | 0 | 27 | 0 | 27 |
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| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |