Clinical trial NCT03771755: Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Extremity Problem
Surgery
Postoperative Pain
Keywords: ibuprofen
acetaminophen
orthopedic
VAS
morphine
opioid
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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

Primary outcomes:
measure: Pain intensity
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
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