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Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal analgesia. This medication is generally safe, well tolerated and effective within recommended daily dose.The purpose of the study is to evaluate the efficacy and safety of Paracetamol Injection as adjuvant to morphine-based post-operative analgesia, as well as to explore the reasonable dosage of paracetamol among Chinese population under above-mentioned circumstance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:Paracetamol Injection | Active Comparator | 325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment |
|
| Placebo:Normal Saline Injcetion | Placebo Comparator | 32.5mLor 50mL iv q6h according to assignment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol injection | Drug | 325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion timeā„15min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine use in 24 hours | Total morhpine use(including PCA and emergency morphine use)in 24 hours. | 24h after the 1st dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity VAS AUC(0-24h) at rest | 0-24h PI VAS AUC(mesured at 1hć3hć6hć12hć24h after the 1st dose of study drug) | |
| Pain Intensity VAS AUC(0-24h) at movement | 0-24h PI VAS AUC(mesured at 1hć3hć6hć12hć24h after the 1st dose of study drug) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fei Liu, Ph.D | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Beijing | Beijing Municipality | 100020 | China | ||
| Beijing Friendship Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35935863 | Derived | Yin F, Ma W, Liu Q, Xiong LL, Wang TH, Li Q, Liu F. Efficacy and safety of intravenous acetaminophen (2 g/day) for reducing opioid consumption in Chinese adults after elective orthopedic surgery: A multicenter randomized controlled trial. Front Pharmacol. 2022 Jul 22;13:909572. doi: 10.3389/fphar.2022.909572. eCollection 2022. |
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| Normal Saline injection | Drug | 32.5mL or 50mL iv q6h,4 doses in 24h.Infushion timeā„15min. |
|
| Morhpine PCA | Drug | Morphine PCA will be connected upon the first dose of study drug(roughly 30min prior to the completion of would suture). Morphine PCA is set as follows:1mg bolus every 5min with background infusion of 0.25mg/h and maximal dose<25mg/4h. |
|
| Incidence of mophine-related ADR | 0-24h after the 1st dose of study drug |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China |
| The South West Hospital | Chongqing | Chongqing Municipality | 400042 | China |
| Fuzhou General Hospital of Nanjing Millitary Command | Fuzhou | Fujian | 350025 | China |
| Liuzhou General Hospital | Liuzhou | Guangxi | 545006 | China |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | 551100 | China |
| The Third Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050051 | China |
| the Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| No.1 People's Hospital of Chenzhou City | Chenzhou | Hunan | 423000 | China |
| Affiliated Hospital,Jiangnan University | Wuxi | Jiangsu | 214062 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Tongji Hospital Affiliated to Tongji University | Shanghai | Shanghai Municipality | 200065 | China |
| West China Hospital | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| Ningbo No.2 Hospital | Ningbo | Zhejiang | 315010 | China |
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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