Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT00892606
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00892606
Study Brief:
Protocol Section:
NCT00892606