CompletedPhase 4Other

Methadone Versus Morphine for Orthopedic Surgery Patients

Sponsored by University of Louisville

NCT ID
NCT00892606
Target Enrollment
75 participants
Start Date
2009-01
Est. Completion
2013-12

About This Study

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.

Conditions Studied

FracturePain, Postoperative

Interventions

  • Methadone
  • Morphine

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Study Locations (1)

University of Louisville Hospital
Louisville, Kentucky, United States

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source