IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction
Completed · Phase 3
Conditions studied: Scoliosis
In brief
This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A total of approximately 15 patients will be required. The purpose is to determine the levels of R, S methadone at various time intervals after drug administration. Patients will receive methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to VAS scores, patient and parental satisfaction with analgesia, and a functional pain assessment.
Key facts
- Study ID
- NCT01205256
- Run by
- University of Virginia
- People needed
- 11
- Starts
- 2009-03-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2016-03-03
Who can join
Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis,
- Age 12 - 19 inclusive
- ASA class I-II.
You may not qualify if…
- Preoperative opioid therapy in previous 2 weeks
- Known hepatic or renal impairment
- Inability to assess pain score due to neurological impairment, hearing impairment
- Allergy to methadone, morphine, fentanyl, propofol or remifentanil
- Pregnant or nursing
- Taking SSRI's, MAOI,anticonvulsants, gabapentin or lyrica
- ASA III or greater patients are excluded
- pre-existing chronic pain
Where it is running
- University of Virginia Health System — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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