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To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. PCA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone i.v. | Experimental | To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) |
|
| Morphine i.v. | Active Comparator | To determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (PCA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone | Drug | dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measuring VAS | Measuring resting and coughing VAS, assessing the intensity of pain | 3h post-operation |
| Measuring VAS | Measuring resting and coughing VAS, assessing the intensity of pain | 24 hours post operation |
| Measuring VAS | Measuring resting and coughing VAS, assessing the intensity of pain | 48 hours post operation |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage | Total dosage of study drugs within 48h. | Within 48h |
| The dosage of other rescue analgesic drugs used within 48h post-operation. | The dosage of other rescue analgesic drugs used within 48h post-operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mundipharma China Ltd. | Mundipharma China Ltd. | Study Chair |
| Mundipharma China Ltd. | Investigational Site Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Beijing | Beijing Municipality | 100022 | China |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Morphine | Drug | dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours |
|
|
| 48hrs |
| The invalid times and the total times of PCA application | The invalid times and the total times of PCA application | 48hrs |
| Satisfaction degree for analgesia | Satisfaction degree for analgesia after the treatment | 48hrs |
| AE occurrence and abnormal lab value | AE and normal lab value will be recorded during the study | 48hrs |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |