A multicenter, randomized, double-blind, placebo-controlled, dose-exploratory phase II clinical trial to evaluating the efficacy and safety of Felbinac Trometamol Injection in the treatment of moderate to severe pain after surgery.Main purpose is preliminary evaluation the effectiveness of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to explore the dosage regimen of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery, and provide data support for later clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
165
Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump. One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).the drug was given 3 times,3 times/day,once every 8 hours.
Placebo diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump. One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).the drug was given 3 times,3 times/day,once every 8 hours.
Shijiazhuang Yiling Pharmaceutical Co.,Ltd
Shijiazhuang, Hebei, China
24h total morphine consumption
The the total amount of morphine within 24 hours after the end of first drug administration
Time frame: up to 24hours after multi-dose
Area under the pain intensity curve(AUC)
Pain intensity under exercise/rest state - area under the time curve
Time frame: up to 24 hours after multi-dose
Press time
The first time to press the analgesic pump for analgesia
Time frame: up to 24 hours after multi-dose
Total number of analgesia pump presses
Total number of analgesic pump presses within 24 hours after the first dose
Time frame: up to 24 hours after multi-dose
The number of effective presses of analgesia pump
The number of effective presses of analgesia pump within 24 hours after the end of the first dose
Time frame: up to 24 hours after multi-dose
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