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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03771755
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Aida Rosita Tantri, Indonesia University

Study Description
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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

Condition or disease Intervention/treatment Phase
Lower Extremity Problem Surgery Postoperative Pain Drug: Ibuprofen Drug: Acetaminophen Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ibuprofen group
800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
 Drug: Ibuprofen
800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Placebo Comparator: Acetaminophen group
1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
 Drug: Acetaminophen
1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 24 hours ]
    demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771755


Locations
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Indonesia
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
More Information
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Publications:

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Responsible Party: Aida Rosita Tantri, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03771755    
Other Study ID Numbers: IndonesiaUAnes026
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aida Rosita Tantri, Indonesia University:
ibuprofen
acetaminophen
orthopedic
 VAS
morphine
opioid
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action