Back to resultsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.
Primary Purpose
Ibuprofen, Nonsteroidal Anti-inflammatory Drug, Intravenous
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ibuprofen
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Ibuprofen
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
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
ibuprofen( 400mg group)
ibuprofen( 800mg group)
placebo group
Arm Description
Patients were randomly divided into the group received respectively IV ibuprofen 400 mg .
Patients were randomly divided into the group received respectively IV ibuprofen 800 mg.
Patients were randomly divided into the group received respectively IV placebo,.
Outcomes
Primary Outcome Measures
the amount of morphine administered
after surgery.
Secondary Outcome Measures
Pain intensity (PI)
the PI was evaluated using patient self-reporting with numerical rating scales (NRS) (0= no pain to 10= intense pain)
The area under the PI-time curve (AUC)
at rest and with movement
Total frequency and effective frequency of PCA
after surgery
Treatment failure rate
the rate of using other non-morphine drugs to remedy analgesia
Patients' evaluation of the study drug
excellent=5, very good=4, good=3, general=2, bad=1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04429282
Brief Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2020 (Anticipated)
Primary Completion Date
June 10, 2020 (Anticipated)
Study Completion Date
June 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Feng, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ibuprofen, Nonsteroidal Anti-inflammatory Drug, Intravenous, Injectable, Pain, Analgesic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen( 400mg group)
Arm Type
Experimental
Arm Description
Patients were randomly divided into the group received respectively IV ibuprofen 400 mg .
Arm Title
ibuprofen( 800mg group)
Arm Type
Experimental
Arm Description
Patients were randomly divided into the group received respectively IV ibuprofen 800 mg.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Patients were randomly divided into the group received respectively IV placebo,.
Intervention Type
Drug
Intervention Name(s)
ibuprofen
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
the amount of morphine administered
Description
after surgery.
Time Frame
during the first 24 hours
Secondary Outcome Measure Information:
Title
Pain intensity (PI)
Description
the PI was evaluated using patient self-reporting with numerical rating scales (NRS) (0= no pain to 10= intense pain)
Time Frame
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.
Title
The area under the PI-time curve (AUC)
Description
at rest and with movement
Time Frame
across 3 time periods (1-24 hours, 6-24 hours, 12-24 hours)
Title
Total frequency and effective frequency of PCA
Description
after surgery
Time Frame
within 24 hours
Title
Treatment failure rate
Description
the rate of using other non-morphine drugs to remedy analgesia
Time Frame
within 24 hours after the operation
Title
Patients' evaluation of the study drug
Description
excellent=5, very good=4, good=3, general=2, bad=1
Time Frame
after 48 hours of medication
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Feng, MD
Phone
08601088325590
Email
yifeng65@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Feng, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Feng, MD
Phone
08601088325590
Email
yifeng65@sina.com
12. IPD Sharing Statement
Learn more about this trial
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.
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