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

• Status: Completed
• Trial end date: 2017-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the reduction of pain following orthopedic low extremity procedures

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indonesia University
• Treatments: Acetaminophen; Ibuprofen; Morphine

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