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Clinical Trial Summary

This study was to evaluate the efficacy and safety of intravenously administered ibuprofen 400mg and 800 mg q6h for the management of moderate to severe postoperative pain in Chinese population.


Clinical Trial Description

This randomized, parallel, double-blind, placebo controlled multi-center clinical study was conducted in 396 patients scheduled to undergo elective general anesthesia laparotomy or orthopedic surgery. Patients were randomly divided into three groups in radio 1:1:1 received respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs was administered intravenously at the time of wound closure and then every 6 hours within 48 hours after the operation. At the end of surgical suture, 5mg morphine was injected intravenously, and then the patient-controlled intravenous analgesia pump was connected. Efficacy was assessed by morphine dosage during the first 24 hours, pain intensity score, and area under the pain-time curve after surgery. Safety was assessed by the incidence of adverse events. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04429282
Study type Interventional
Source Peking University People's Hospital
Contact Yi Feng, MD
Phone 08601088325590
Email yifeng65@sina.com
Status Recruiting
Phase Phase 3
Start date June 10, 2020
Completion date June 10, 2020

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