Overview

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.

Status:
Recruiting
Trial end date:
2020-06-10
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yi Feng, MD
Treatments:
Ibuprofen
Criteria
Inclusion Criteria:

- Enrollment was open to patients undergoing scheduled abdominal surgery (intestinal or
lower abdomen) or orthopedic surgery (such as knee arthroplasty or shoulder joint
reconstruction) under general anesthesia with endotracheal intubation and were
expected to require patient-controlled intravenous analgesia (PCIA) pump for more than
24h for moderate to severe pain after surgery.

Exclusion Criteria:

- Those who can not understand the NRS score and cooperate with the evaluation; those
who had head trauma or complicated with organic lesions of the central nervous system
within 4 weeks before operation; those who developed coagulation dysfunction or took
anticoagulants and antiplatelet drugs; those with a history of severe
cardio-cerebrovascular disease, heart failure; those with liver and kidney
dysfunction, severe endocrine system diseases, mental illness; those with a history of
peptic ulcer or bleeding; those who did not control grade 2 or above hypertension or
were still taking two or more of antihypertensive drugs such as angiotensin converting
enzyme inhibitors (ACEI), angiotensin converting enzyme antagonists (ARB) and
diuretics at admission; Increased toxicity due to the interaction of methotrexate,
lithium preparations, etc. with the test drug; use of NSAIDs or analgesic muscle
relaxants within 24 hours before operation, narcotic dependence or tolerance; allergy
to ibuprofen or other NSAIDs; pregnant or lactating women