Status:
COMPLETED
Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
Lead Sponsor:
Indonesia University
Conditions:
Lower Extremity Problem
Surgery
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the reduction of pain following orthopedic low extremity procedures
Detailed Description
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Patients undergoing orthopedic low extremity surgery were screened. Eligible subje...
Eligibility Criteria
Inclusion
- Scheduled for Orthopedic Low Extremity Surgery with general anesthesia and anticipated need post operative IV analgesia with anticipated use of \>48 hours.
- Adequate IV access.
- Anticipated hospital stay\>48 hours.
- Age 18-70 years old with physical status ASA I- III.
- Patients able to fill informed consent sheet.
Exclusion
- patients with use of analgesia, muscle relaxants, NSAIDs and sedatives less than 24 hours to study drug administration
- anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
- historical or at higher risk intracerebral bleeding, history of allergy or hypersensitive to NSAID, Ibuprofen, Acetaminophen or opioid
- pregnant or nursing
- body weight less than 30 kg
- any active clinically significant bleeding or have underlying platelet dysfunction and/or receiving full dose anticoagulation therapy
- GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
- on dialysis or renal dysfunction
- impaired liver function
- inability to achieve hemostasis or inability to close surgical incision prior to operating room discharge
- operative procedure includes organ transplant, pre-and intra- operative procedure utilized for the prevention of pre- or post-operative pain (i.e, epidural or nerve blocks)
- received anoher investigational drug within the past 30 days
- known or suspected history of alcohol or drug abuse
- severe infection and/or inflammatory disease
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03771755
Start Date
July 1 2017
End Date
November 30 2017
Last Update
August 20 2020
Active Locations (1)
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1
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430