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Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.
Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 550 mg naproxen sodium and 30mg codeine | Experimental | Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. |
|
| 300 mg paracetamol and 30 mg codeine | Active Comparator | Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. |
|
| Placebo | Placebo Comparator | Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 550 mg naproxen sodium and 30mg codeine | Drug | Postoperative contramal consumption, pain intensity, side effects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contramal consumption | To assess contramal consumption | Postoperative 24 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | nausea and vomiting | postoperative 24 hour |
| Pain intensity | To assess postoperative pain intensity by visual analog scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reyhan Polat, MD | Contact | +905326734310 | reyhanp9@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Reyhan Polat, MD | Ministry of Health | Principal Investigator |
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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 |
|---|---|
| D009288 | Naproxen |
| D003061 | Codeine |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| 300 mg paracetamol and 30 mg codeine | Drug | Postoperative contramal consumption, pain intensity, side effects |
|
|
| placebo tablet | Drug | Postoperative contramal consumption, pain intensity, side effects |
|
| postoperative 24 hour |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |