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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01205256
First received: September 16, 2010
Last updated: September 17, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Scoliosis
 Drug: methadone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction

Resource links provided by NLM:

MedlinePlus related topics: Scoliosis
U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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)


Enrollment: 11
Study Start Date: March 2009
Arms Assigned Interventions
Experimental: Methadone
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.

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.
  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205256

Locations
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Christopher Stemland, MD UVA Anesthesiology
  More Information

Publications:

Responsible Party: Christopher Stemland, MD, UVA Anesthesiology
ClinicalTrials.gov Identifier: NCT01205256     History of Changes
Other Study ID Numbers: 14145
Study First Received: September 16, 2010
Last Updated: September 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Methadone pharmacokinetics in adolescents

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013