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This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tegileridine | Experimental | The loading iv dose: 0.75mg The PCIA dose:0.05mg Lockout time: 10min |
|
| oliceridine | Experimental | The loading iv dose: 1.5mg The PCIA dose:0.35mg Lockout time: 6min |
|
| morphine | Active Comparator | The loading iv dose: 3mg The PCIA dose:1mg Lockout time: 6min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tegileridine | Drug | single dose+PCA dose |
| |
| Oliceridine |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion | "resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain | during the first 24 hours after starting a loading dose of test drug infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Resting-state pain and exercise-state pain intensity | Resting-state pain and exercise-state pain intensity are assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain | Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 241 Huaihai West Road, Xuhui District, Shanghai | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C586842 | ((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
single dose+PCA dose |
|
| Morphine | Drug | single dose+PCA dose |
|
| Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion |
"exercise-state pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and |
| Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose |
| total pain relief (TOTPAR) scores | Time-weighted sum of resting and moving state pain relief scores | 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose |
| the percentage of patients receiving rescue analgesia | the percentage of patients receiving rescue analgesia | from 0-24 hours after the first loading dose |
| length of bed stay | length out of bed | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months. |
| Length of hospital stay | postoperative length of hospital stay | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months. |
| incidence of Postoperative nausea and vomiting | incidence rate of PONV | the first 24 hours after surgery |
| incidence rate of respiratory depression | respiratory depression is defined as respiratory rate < 8 and/or SpO2<90% | the first 24 hours after surgery |
| analgesia satisfaction | satisfaction evaluation using 0-100 scale | the first 24 hours after surgery |
| pressing times of postoperative analgesic pump | the first 24 hours after surgery |
| total doses of postoperative analgesic pump | the first 24 hours after surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |