Methadone Versus Morphine for Orthopedic Surgery Patients

Completed · Phase 4

Conditions studied: Fracture, Pain, Postoperative

In brief

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 hypothesize that when given with ketamine before surgical incision, methadone is more effective than morphine in reducing postoperative morphine consumption and reducing pain during movement.

Key facts

Study ID

NCT00892606

Run by

University of Louisville

People needed

75

Starts

2009-01-01

Expected to finish

2013-12-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Louisville Hospital — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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