A Phase 3 interventional study of methadone in Scoliosis, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2016-03-03.
Sponsored by University of Virginia · Phase 3, Interventional, and Health services research
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.
Study Procedures Following Surgery:
603 studies on the registry are indexed under Scoliosis; 141 are open to participants now.
This study's enrollment of 11 is below the median of 44 across 350 interventional studies indexed under Scoliosis.
Browse Scoliosis studies →University of Virginia is the lead sponsor of 672 studies on the registry; 138 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
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0.25mg/kg IV of racemic methadone at the induction of anesthesia.
Drug: methadone
0.25mg/kg IV of racemic methadone at the induction of anesthesia.
Also known as: 0.25mg/kg IV of racemic methadone
methadone levels
Tmax (time to maximum methadone concentration) Cmax (maximum concentration) T1/2 (half-life) AUC last (area under the curve from time 0 to last sample point) AUC inf (area under the curve from time 0 to infinity) VZ (Volume of distribution in the terminal phase) CL (clearance)
Time frame: 0min, 5min, 10 min, 15min, 20 min, 40 min, 1, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs.
Plan to share: No
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methadone