- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01205256
IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction
March 1, 2016 updated by: Christopher Stemland, MD, University of Virginia
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 Overview
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.
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methadone
0.25mg/kg IV of racemic methadone at the induction of anesthesia.
|
0.25mg/kg IV of racemic methadone at the induction of anesthesia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
methadone levels
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.
|
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)
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Stemland, MD, UVA Anesthesiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vinik HR, Kissin I. Rapid development of tolerance to analgesia during remifentanil infusion in humans. Anesth Analg. 1998 Jun;86(6):1307-11. doi: 10.1097/00000539-199806000-00033.
- Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
- Gourlay GK, Willis RJ, Wilson PR. Postoperative pain control with methadone: influence of supplementary methadone doses and blood concentration--response relationships. Anesthesiology. 1984 Jul;61(1):19-26.
- Gourlay GK, Wilson PR, Glynn CJ. Pharmacodynamics and pharmacokinetics of methadone during the perioperative period. Anesthesiology. 1982 Dec;57(6):458-67. doi: 10.1097/00000542-198212000-00005. No abstract available.
- Holtman JR Jr, Wala EP. Characterization of the antinociceptive and pronociceptive effects of methadone in rats. Anesthesiology. 2007 Mar;106(3):563-71. doi: 10.1097/00000542-200703000-00022.
- Berde CB, Beyer JE, Bournaki MC, Levin CR, Sethna NF. Comparison of morphine and methadone for prevention of postoperative pain in 3- to 7-year-old children. J Pediatr. 1991 Jul;119(1 Pt 1):136-41. doi: 10.1016/s0022-3476(05)81054-6.
- Claar RL, Walker LS. Functional assessment of pediatric pain patients: psychometric properties of the functional disability inventory. Pain. 2006 Mar;121(1-2):77-84. doi: 10.1016/j.pain.2005.12.002. Epub 2006 Feb 9.
- Davis AM, Inturrisi CE. d-Methadone blocks morphine tolerance and N-methyl-D-aspartate-induced hyperalgesia. J Pharmacol Exp Ther. 1999 May;289(2):1048-53.
- Shir Y, Shenkman Z, Shavelson V, Davidson EM, Rosen G. Oral methadone for the treatment of severe pain in hospitalized children: a report of five cases. Clin J Pain. 1998 Dec;14(4):350-3. doi: 10.1097/00002508-199812000-00013.
- Dale O, Hoffer C, Sheffels P, Kharasch ED. Disposition of nasal, intravenous, and oral methadone in healthy volunteers. Clin Pharmacol Ther. 2002 Nov;72(5):536-45. doi: 10.1067/mcp.2002.128386.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
September 16, 2010
First Submitted That Met QC Criteria
September 17, 2010
First Posted (Estimate)
September 20, 2010
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Scoliosis
-
Manhattan Physical Medicine and Rehabilitation,...RecruitingScoliosis Idiopathic | Scoliosis; Adolescence | Scoliosis; Lumbar RegionUnited States
-
Stanford UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not yet recruitingScoliosis Idiopathic | Spondylolisthesis | Scoliosis; Adolescence | Kyphosis | Juvenile; Scoliosis | Scoliosis;CongenitalUnited States
-
Seattle Children's HospitalJohns Hopkins University; Duke University; Vanderbilt University; University of... and other collaboratorsRecruitingScoliosis Idiopathic | Spondylolisthesis | Scoliosis; Adolescence | Kyphosis | Juvenile; Scoliosis | Scoliosis;CongenitalUnited States
-
Children's National Research InstituteNational Institute for Biomedical Imaging and Bioengineering (NIBIB); Kitware...RecruitingScoliosis Idiopathic | Scoliosis; JuvenileUnited States
-
University of HaifaRecruitingScoliosis Idiopathic | Scoliosis; AdolescenceIsrael
-
University of PecsCompletedScoliosis Idiopathic | Scoliosis, SevereHungary
-
Istituto Scientifico Italiano Colonna VertebraleCompletedScoliosis Idiopathic | Scoliosis; AdolescenceItaly
-
Istituto Scientifico Italiano Colonna VertebraleRecruiting
-
Stanford UniversityRecruitingScoliosis; Juvenile | Scoliosis; AdolescenceUnited States
-
Istanbul Gelisim UniversityCompletedScoliosis Idiopathic | Scoliosis; AdolescenceTurkey
Clinical Trials on methadone
-
Pontificia Universidad Catolica de ChileCompletedPain, Postoperative | Opioid Use | Methadone Overdose of Undetermined IntentChile
-
Washington University School of MedicineCompleted
-
University of Southern DenmarkCompletedPain, Postoperative | Pain, Post Operative | Analgesics, Opioid | MethadoneDenmark
-
Washington University School of MedicineCompleted
-
The Miriam HospitalUnknownOpioid-Related DisordersUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingChronic Pain | Opioid Use Disorder | MethadoneUnited States
-
Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS)WithdrawnPolyneuropathy | HIV-associated NeuropathyUnited States
-
Washington University School of MedicineCompleted
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedOpiate DependenceUnited States
-
Friends Research Institute, Inc.CompletedOpiate DependenceUnited States