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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 abdominal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group 1 | Experimental |
| |
| Experimental Group 2 | Experimental |
| |
| Placebo Comparator | Placebo Comparator |
| |
| Active Comparator | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: YZJ-4729 | Drug | Loading dose + demand dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences Over 24 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 24 hours. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The Time to first using rescue analgesics | 24 hours | |
| The proportion of subjects using rescue analgesics | 24 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 |
|---|---|---|---|---|---|---|
| Cangzhou Central Hospital | Cangzhou | China | ||||
| Cangzhou People's Hospital |
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| Placebo Comparator: Saline | Drug | Loading dose + demand dose |
|
| Active Comparator: Morphine | Drug | Loading dose + demand dose |
|
| 24 hours |
| The cumulative dose used of rescue analgesics | 24 hours |
| the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours | 24 hours |
| the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours | 24 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. | 24 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. | 24 hours |
| Cangzhou |
| China |
| Changde First People's Hospital | Changde | China |
| Changsha Hospital Affiliated to Hunan University | Changsha | China |
| The Fourth Hospital OF Changsha | Changsha | China |
| The Third Xiangya Hospital of Central South University | Changsha | China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| The Second People's Hospital of Chengdu | Chengdu | China |
| The Third People's Hospital of Chengdu | Chengdu | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | China |
| The First Hospital of Jilin University | Ch’ang-ch’un | China |
| Affiliated Zhongshan Hospital of Dalian University | Dalian | China |
| Deyang People's Hospital | Deyang | China |
| Dongguan People's Hospital | Dongguan | China |
| Ganzhou People's Hospital | Ganzhou | China |
| The First People's Hospital of Guangyuan | Guangyuan | China |
| Guangdong Province Traditional Chinese Medical Hospital | Guangzhou | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | China |
| The First Affiliated Hospital of Jinan University | Guangzhou | China |
| Haikou People's Hospital | Haikou | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Ha’erbin | China |
| The Second People's Hospital of Hefei | Hefei | China |
| The First Affiliated Hospital of University of South China | Hengyang | China |
| Huzhou Central Hospital | Huzhou | China |
| The First Hospital of Jiaxing | Jiaxing | China |
| Liuzhou People's Hospital | Liuzhou | China |
| Liuzhou Workers' Hospital | Liuzhou | China |
| Luoyang Central Hospital | Luoyang | China |
| Ma'anshan People's Hospital | Ma’anshan | China |
| Mianyang Central Hospital | Mianyang | China |
| JiangXi Provincial People's Hospital | Nanchang | China |
| The Second Nanning People's Hospital | Nanning | China |
| The Second People's Hospital of Neijiang | Neijiang | China |
| Ningbo Medical Center Lihuili Hospital | Ningbo | China |
| Qingdao Central Hospital of Rehabilitation University | Qingdao | China |
| Shanghai First Maternity and Infant Hospital | Shanghai | China |
| Shanghai Fourth People's Hospital | Shanghai | China |
| Taizhou People's Hospital | Taizhou | China |
| The Second Hospital of Tianjin Medical University | Tianjin | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | China |
| Wuhan Third Hospital | Wuhan | China |
| Affiliated Hospital of Jiangnan University | Wuxi | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| Zhongshan Hospital Xiamen University | Xiamen | China |
| The Second People's Hospital of Yibin | Yibin | China |
| Zhangzhou Municipal of Fujian Province | Zhangzhou | China |
| Henan Provincial People's Hospital | Zhengzhou | China |
| Zhuzhou Central Hospital | Zhuzhou | China |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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