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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01205256
First Posted: September 20, 2010
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Stemland, MD, University of Virginia
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Christopher Stemland, MD, 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. ]
    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
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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.
Other Name: 0.25mg/kg IV of racemic methadone

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

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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Attending Anesthesiologist, University of Virginia
ClinicalTrials.gov Identifier: NCT01205256     History of Changes
Other Study ID Numbers: 14145
First Submitted: September 16, 2010
First Posted: September 20, 2010
Last Update Posted: March 3, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Christopher Stemland, MD, University of Virginia:
Methadone pharmacokinetics in adolescents

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