Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lower Extremity Problem, Surgery, Postoperative Pain

Intervention / Treatment
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* Drug: Ibuprofen
* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ibuprofen group<br>800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes | Drug: Ibuprofen<br>* 800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes<br>|
| Placebo Comparator: Acetaminophen group<br>1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes | Drug: Acetaminophen<br>* 1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ibuprofen, acetaminophen, orthopedic, VAS, morphine, opioid