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This is a multi-center, randomized, double-blind, placebo/active-controlled study. 160 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542 dose level 1 | Experimental | Patients administrated with HSK21542 dose level 1 |
|
| HSK21542 dose level 2 | Experimental | Patients administrated with HSK21542 dose level 2 |
|
| Placebo control | Placebo Comparator | Patients administrated with placebo |
|
| Actice control | Active Comparator | Patients administrated with morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 dose level 1 | Drug | Patients administrated with HSK21542 dose level 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) | Sum of Pain Intensity Differences (SPID) of each group | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) in other time frame | Sum of Pain Intensity Differences (SPID) in other time frame | 0-8 hours, 0-24 hours, 24-48 hours |
| Number of times rescue analgesic medications were administered. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
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| HSK21542 dose level 2 |
| Drug |
Patients administrated with HSK21542 dose level 2 |
|
| Placebo | Drug | Patients administrated with placebo |
|
| morphine | Drug | Patients administrated with morphine |
|
Number of times rescue analgesic medications were administered.
| 48 hours |
| Total morphine consumption | Total morphine consumption of each group | 48 hours |
| Proportion of subjects experiencing nausea and/or vomit | Proportion of subjects experiencing nausea and/or vomit of each group | 48 hours |
| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| 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 |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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