Status:
COMPLETED
IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction
Lead Sponsor:
University of Virginia
Conditions:
Scoliosis
Eligibility:
All Genders
12-19 years
Phase:
PHASE3
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 methado...
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...
Eligibility Criteria
Inclusion
- Pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis,
- Age 12 - 19 inclusive
- ASA class I-II.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01205256
Start Date
March 1 2009
End Date
April 1 2010
Last Update
March 3 2016
Active Locations (1)
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1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908