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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04429282
Other study ID # 2017PHA019
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 10, 2020
Est. completion date June 10, 2020

Study information

Verified date June 2020
Source Peking University People's Hospital
Contact Yi Feng, MD
Phone 08601088325590
Email yifeng65@sina.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 396
Est. completion date June 10, 2020
Est. primary completion date June 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ibuprofen
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
Placebo

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Yi Feng, MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the amount of morphine administered after surgery. during the first 24 hours
Secondary Pain intensity (PI) the PI was evaluated using patient self-reporting with numerical rating scales (NRS) (0= no pain to 10= intense pain) 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.
Secondary The area under the PI-time curve (AUC) at rest and with movement across 3 time periods (1-24 hours, 6-24 hours, 12-24 hours)
Secondary Total frequency and effective frequency of PCA after surgery within 24 hours
Secondary Treatment failure rate the rate of using other non-morphine drugs to remedy analgesia within 24 hours after the operation
Secondary Patients' evaluation of the study drug excellent=5, very good=4, good=3, general=2, bad=1 after 48 hours of medication
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