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Completed

NCT Number: NCT01773005

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Pain Institute Hahnemann Hospital

Philadelphia, Pennsylvania, 19102, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ofirmev

Drug

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 names: Intravenous Acetaminophen

Caldolor

Drug

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 names: Intravenous Ibuprofen

Primary outcomes

  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 outcomes

  1. Quality of Recovery (QoR40 scale)

    Time frame: Post-operative Day one

    Patient satisfaction score

Other outcomes

  1. Side effects

    Time frame: Post-operative Day one to five (or hospital discharge)

    Incidence of opioid-related side effects

Sponsors and collaborators

Lead sponsor

Anita Gupta

Other

Collaborators

  • Cumberland Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 21, 2013
Registry last updated
Feb 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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