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

Not Applicable

Completed

• Conditions: Postoperative Pain; Lower Extremity Problem; Surgery
• Interventions: Drug: Ibuprofen; Drug: Acetaminophen

• Registration Number: NCT03771755
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-09
• Study First Posted: 2018-12-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen group	Ibuprofen	800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Acetaminophen group	Acetaminophen	1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes

Primary Outcome Measures

Name	Time	Method
Pain intensity	24 hours	demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia