Scoliosis
Conditions
Keywords
Methadone pharmacokinetics in adolescents
Brief summary
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.
Detailed description
Study Procedures Following Surgery: * VAS scores will be recorded at intervals of 1,2,3,4,5,6,8,12,16,20,24, 36, 48 , 72 hrs (after extubation). * Blood samples for PK will require 5ml per sample and may be obtained from an existing IV or direct phlebotomy and will be obtained at 0min, 5min, 10 min, 15min, 20 min, 40 min, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs after study drug administration.
Interventions
DRUGmethadone
0.25mg/kg IV of racemic methadone at the induction of anesthesia.
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis, * Age 12 - 19 inclusive * ASA class I-II.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| methadone levels | 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. | 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) |
Countries
United States
Outcome results
None listed