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

Last updated: June 17, 2020
Sponsor: Yi Feng, MD
Overall Status: Active - Recruiting

Phase

3

Condition

Pain

Treatment

N/A

Clinical Study ID

NCT04429282
2017PHA019
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 396
Study Start date:
June 10, 2020
Estimated Completion Date:
June 10, 2020

Study 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.

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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