A Prospective, Randomized, Double-blind Study Assessing the Efficacy of Intravenous (IV) Ibuprofen Versus IV Acetaminophen for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Ibuprofen
- Conditions
- Lower Extremity Problem
- Sponsor
- Indonesia University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 subjects were then randomized into treatment group (intravenous ibuprofen) and control group (intravenous acetaminophen). In case required, patients from both group will be given Morphine (PCA) 1-2 mg every 5 minutes.
Investigators
Aida Rosita Tantri
Principal Investigator
Indonesia University
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Ibuprofen group
800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Intervention: Ibuprofen
Acetaminophen group
1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Intervention: Acetaminophen
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 24 hours
demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.