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Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries

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ClinicalTrials.gov Identifier: NCT01773005
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Anita Gupta, Hahnemann University Hospital

Brief Summary:
The objective of this study is to compare the effectiveness and of perioperative use of Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.

Condition or disease Intervention/treatment Phase
Pain Drug: Ofirmev Drug: Caldolor Phase 4

Detailed Description:

Patients undergoing total knee or hip arthroplasty procedures at University Pain Institute at Hahnemann will be included in this study.

Following Institutional Review Board's approval, eligible patients will be selected from the Pre Admission Testing for total knee or hip arthroplasty surgeries planned at Hahnemann University Hospital.

The cases will be randomized in a 1:1 ratio into either Group 1 or Group 2. Group 1 will receive 800 mg Caldolor at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total up to 120 hours (5 days) Group 2 will receive 800 mg Caldolor at the induction of anesthesia and 1000 mg Ofirmev at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge or for a total up to 120 hours (5 days)

After the surgery, at the request of the patient they could receive morphine administered by patient-controlled analgesia pump, or by hospital staff.

The analgesics and procedures involved in this study are all standard of care drugs prescribed and administered by the attending anesthesiologist for control of total knee or hip arthroplasty surgery related pain. Data collected for every patient will exist in the patient's medical chart as part of their standard medical care. No additional patient procedures or activities are mandated by this study.

The data collection and analysis will be completed in duration of 1 year


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Single Center, Randomized, Open-Label Trial to Compare the Safety and Efficacy of Caldolor Used Singly and in Combination With Ofirmev in Total Knee or Hip Arthroplasty Surgery Patients
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Caldolor
Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)
Drug: Caldolor
Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)
Other Name: Intravenous Ibuprofen
Active Comparator: Ofirmev
Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days)
Drug: Ofirmev
Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days)
Other Name: Intravenous Acetaminophen
Drug: Caldolor
Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)
Other Name: Intravenous Ibuprofen



Primary Outcome Measures :
  1. Visual Analog Score (VAS) [ Time Frame: Before surgery to Post-operative Day 5 (or Hospital Discharge) ]
    First Post-op 100mm VAS pain score at rest and with movement


Secondary Outcome Measures :
  1. Quality of Recovery (QoR40 scale) [ Time Frame: Post-operative Day one ]
    Patient satisfaction score


Other Outcome Measures:
  1. Side effects [ Time Frame: Post-operative Day one to five (or hospital discharge) ]
    Incidence of opioid-related side effects



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients age 18-70 scheduled for total knee or hip arthroplasty surgery
  • American Society of Anesthesiology physical status I, II, III

Exclusion Criteria:

  • Impaired liver function
  • History of substance abuse or chronic pain
  • Patients known to be hypersensitive to any of the components of Caldolor or Ofirmev
  • Patients less than 18 years of age.
  • Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions.
  • Be pregnant or nursing
  • Be otherwise unsuitable for the study, in the opinion of the Investigator.

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): NCT01773005


Locations
United States, Pennsylvania
University Pain Institute Hahnemann Hospital
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Anita Gupta
Cumberland Pharmaceuticals
Investigators
Study Director: Kirtanaa Voralu, MS Associate Director Research Management

Responsible Party: Anita Gupta, Associate Professor, Hahnemann University Hospital
ClinicalTrials.gov Identifier: NCT01773005     History of Changes
Other Study ID Numbers: CP-001-12
20121232 ( Other Grant/Funding Number: Cumberland )
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anita Gupta, Hahnemann University Hospital:
Anesthetics, Intravenous

Additional relevant MeSH terms:
Anesthetics
Acetaminophen
Ibuprofen
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action