IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction

NCT01205256 | Completed Phase 3

• 1 other identifier: 14145
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Keywords

Methadone pharmacokinetics in adolescents

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

Study Arms (1)

Methadone

EXPERIMENTAL

0.25mg/kg IV of racemic methadone at the induction of anesthesia.

Drug: methadone

Interventions

methadone DRUG

0.25mg/kg IV of racemic methadone at the induction of anesthesia.

Also known as: 0.25mg/kg IV of racemic methadone

Methadone

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (10)

• 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.

  PMID: 6742480 BACKGROUND

• 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.

  PMID: 6128949 BACKGROUND

• 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.

  PMID: 16480823 BACKGROUND

• 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.

  PMID: 1826329 BACKGROUND

• 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.

  PMID: 9620525 BACKGROUND

• 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.

  PMID: 10215686 BACKGROUND

• 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.

  PMID: 17325516 BACKGROUND

• 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.

  PMID: 2066846 BACKGROUND

• 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.

  PMID: 9874015 BACKGROUND

• 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.

  PMID: 12426517 BACKGROUND

MeSH Terms

Conditions

Scoliosis

Interventions

Methadone

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Christopher Stemland, MD

  UVA Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: March 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 3, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)