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The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Placebo Comparator |
| |
| Treatment group D | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8554 Injection | Drug | SHR8554 Injection; high dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 24 Hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS. | 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、18 、12-18 Hours | time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、18 、12-18 hours) to yield values on the 0-10 NPRS. | 6-hours、12-hours、18-hours、12-18 hours |
| Time of first use of remedial analgesic medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology | Wuhan | Wuhan | 430021 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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Parallel Assignment
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| SHR8554 Injection |
| Drug |
SHR8554 Injection; low dose |
|
| Placebo | Drug | Saline Solution |
|
| Morphine | Drug | Morphine |
|
The first time to use parecoxib sodium for injection |
| 24-hours |
| Cumulative use of remedial analgesics from 0h to 24h | Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection | 24-hours |
| Participant ' satisfaction score for analgesia treatment | Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied. | 24-hours |
| Investigator satisfaction score for analgesia treatment | Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied. | 24-hours |
| 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 |