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

NCT ID: NCT04429282

Last Updated: 2020-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-10
• Study Completion Date: 2020-06-10

Brief 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.

Detailed 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.

Conditions

Ibuprofen; Nonsteroidal Anti-inflammatory Drug; Intravenous; Injectable; Pain; Analgesic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ibuprofen( 400mg group)

Patients were randomly divided into the group received respectively IV ibuprofen 400 mg .

Group Type: EXPERIMENTAL

ibuprofen

Intervention Type: DRUG

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.

ibuprofen( 800mg group)

Patients were randomly divided into the group received respectively IV ibuprofen 800 mg.

Group Type: EXPERIMENTAL

ibuprofen

Intervention Type: DRUG

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 group

Patients were randomly divided into the group received respectively IV placebo,.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Feng, MD

OTHER

Sponsor Role: lead

Responsible Party

Yi Feng, MD

Director of department of anesthesiology and painmanagement

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Feng, MD

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Feng, MD

Role: CONTACT

yifeng65@sina.com

08601088325590

Facility Contacts

Yi Feng, MD

Role: primary

yifeng65@sina.com

08601088325590

Other Identifiers

2017PHA019

Identifier Type: -

Identifier Source: org_study_id