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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
396
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.
Placebo
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGthe amount of morphine administered
after surgery.
Time frame: during the first 24 hours
Pain intensity (PI)
the PI was evaluated using patient self-reporting with numerical rating scales (NRS) (0= no pain to 10= intense pain)
Time frame: at 0 hour,1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours and 48 hours immediately after the first administration.
The area under the PI-time curve (AUC)
at rest and with movement
Time frame: across 3 time periods (1-24 hours, 6-24 hours, 12-24 hours)
Total frequency and effective frequency of PCA
after surgery
Time frame: within 24 hours
Treatment failure rate
the rate of using other non-morphine drugs to remedy analgesia
Time frame: within 24 hours after the operation
Patients' evaluation of the study drug
excellent=5, very good=4, good=3, general=2, bad=1
Time frame: after 48 hours of medication
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