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The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following Orthopedic surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental |
| |
| Experimental Group 2 | Experimental |
| |
| Experimental Group 3 | Experimental |
| |
| Placebo Comparator | Placebo Comparator |
| |
| Active Comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YZJ-4729 | Drug | Loading dose + demand dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The sum of pain intensity differences in pain score over 48 hours at rest | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The time of first using of rescue analgesics | 0-48 hours | |
| The proportion of subjects using rescue analgesics | 0-48 hours | |
| The number of times for rescue analgesics using |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | China | ||||
| Chengdu Second People's Hospital |
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| Placebo Comparator: Saline | Drug | Loading dose + demand dose |
|
| Active Comparator: Morphine | Drug | Loading dose + demand dose |
|
| 0-48 hours |
| The cumulative dose used of rescue analgesics | 0-48 hours |
| The resting Sum of Pain Intensity Differences Over 12,24,24~48 | 0-48 hours |
| The active Sum of Pain Intensity Differences Over 12,24,48,24~48 | 0-48 hours |
| Participant satisfaction scores for analgesia treatment | Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 1 to 5, with 1 representing dissatisfied and 5 representing very satisfied | 48 hours |
| Investigator satisfaction scores for analgesia treatment | Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied | 48 hours |
| Chengdu |
| China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| The Third People's Hospital of Chengdu | Chengdu | China |
| The First Hospital of Jilin University | Ch’ang-ch’un | China |
| Dalian University Affiliated Zhongshan Hospital | Dalian | China |
| Dongguan People's Hospital | Dongguan | China |
| The First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| The Second People's Hospital of Hefei | Hefei | China |
| Jinhua Central Hospital | Jinhua | China |
| Mianyang Central Hospital | Mianyang | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | China |
| Zhongda Hospital Southeast University | Nanjing | China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | China |
| The First Affiliated Hospital of Ningbo University | Ningbo | China |
| The Second Affiliated Hospital of Fujian Medical University | Quanzhou | China |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China |
| Shanghai First People's Hospital | Shanghai | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | China |
| Suzhou University Affiliated Second Hospital | Suzhou | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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