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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-004075-36 |
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| Name | Class |
|---|---|
| MDS Pharma Services | INDUSTRY |
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The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test drug | Experimental |
| |
| Reference drug | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol (acetaminophen) | Drug | Four 100 mL, 15 min IV infusions at six hour intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of PCA-administered morphine consumed during first six hours of study drug treatment | 6 hours from first (of four) study drug doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keyvan Tadjalli Mehr, MD, MSc | Baxter Deutschland GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Réthy Pál Kórház-Rendelőintézet | Békéscsaba | Hungary | ||||
| Semmelweis Egyetem Ortopédiai Klinika |
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| Paracetamol 1% solution | Drug | Four 100 mL, 15 min IV infusions at six hour intervals |
|
| 0.9% sodium chloride solution | Drug | Four 100 mL, 15 min IV infusions at six hour intervals |
|
|
| Budapest |
| Hungary |
| Esztergom Város Önkormányzat Vaszary Kolos Kórháza | Esztergom | Hungary |
| Petz Aladár Megyei Oktató Kórház | Győr | Hungary |
| Bács-Kiskun Megyei Önkormányzat Kórháza | Kecskemét | Hungary |
| SZTE ÁOK Ortopédiai Klinika | Szeged | Hungary |
| Tolna Megyei Önkormányzat Balassa János Kórháza | Szekszárd | Hungary |
| Fejér Megyei Szent György Kórház | Székesfehérvár | Hungary |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D012996 | Solutions |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
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