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

University of Indonesia (UI)

Status

Completed

Conditions

Postoperative Pain

Surgery

Lower Extremity Problem

Treatments

Drug: Ibuprofen

Drug: Acetaminophen

Study type

Interventional

Funder types

Other

Identifiers

NCT03771755

IndonesiaUAnes026

Details and patient eligibility

About

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

Full 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.

Enrollment

62 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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