Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/14/2017 |
| Start Date: | December 2012 |
| End Date: | December 2014 |
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
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.
Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.
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
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
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.
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