Status:
COMPLETED
Methadone Versus Morphine for Orthopedic Surgery Patients
Lead Sponsor:
University of Louisville
Conditions:
Fracture
Pain, Postoperative
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The investigators propose to compare analgesia by methadone and ketamine with a combination of morphine and ketamine in orthopedic surgery patients with moderate to severe pain. The investigators hypo...
Detailed Description
Patients will receive 1-4 mg midazolam before being transferred to the operating room. All patients will receive standard ASA monitoring. In the operating room, the anesthesiologist will open a random...
Eligibility Criteria
Inclusion
- ASA I-III
- Ages 18-65 years
- Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
- Surgery expected to last more than one hour
- Patient expected to have moderate to severe post-operative pain
- Patient refused regional anesthesia or has a contraindication to regional anesthesia
Exclusion
- Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
- Difficulty or inability to understand the study or protocol
- Known renal or hepatic dysfunction
- BMI\> 35
- Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
- Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
- Pregnancy
- Taking preoperative opioids for more than 2 weeks before the surgery
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00892606
Start Date
January 1 2009
End Date
December 1 2013
Last Update
June 14 2017
Active Locations (1)
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1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202