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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Ibuprofen; Nonsteroidal Anti-inflammatory Drug; Intravenous; Injectable; Analgesic
• Intervention / Treatment: Drug: Placebo; Drug: ibuprofen

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.

• Study Type: Interventional
• Enrollment (Anticipated): 396
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yi Feng, MD; Phone Number: 08601088325590; Email: yifeng65@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Yi Feng, MD; Phone Number: 08601088325590; Email: yifeng65@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ibuprofen( 400mg group); Patients were randomly divided into the group received respectively IV ibuprofen 400 mg .	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.
Experimental: ibuprofen( 800mg group); Patients were randomly divided into the group received respectively IV ibuprofen 800 mg.	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 Comparator: placebo group; Patients were randomly divided into the group received respectively IV placebo,.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the amount of morphine administered	after surgery.	during the first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)
Total frequency and effective frequency of PCA	after surgery	within 24 hours
Treatment failure rate	the rate of using other non-morphine drugs to remedy analgesia	within 24 hours after the operation
Patients' evaluation of the study drug	excellent=5, very good=4, good=3, general=2, bad=1	after 48 hours of medication

Collaborators and Investigators

• Sponsor: Yi Feng, MD

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2020
• Primary Completion (Anticipated): June 10, 2020
• Study Completion (Anticipated): June 10, 2020

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 19, 2020
• Last Update Submitted That Met QC Criteria: June 17, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 2017PHA019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No