Methadone in Pediatric Anesthesiology II

Overview

Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion. Our secondary goal is to determine the pharmacokinetics of IV methadone in children (0.3 and 0.4 mg/kg).

Full Title of Study: “Methadone in Pediatric Anesthesia II”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2018

Detailed Description

Randomized, controlled, modified dose-escalation design. Patients receive standard monitoring for anesthesia and postoperative care. Surgical and anesthesia (except for opioid use) care are not altered for study purposes. All patients are induced by propofol and muscle relaxants. In the first cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid at anesthesiologists' discretion) or methadone HCl (0.4 mg/kg ideal body weight, IBW). In the second cohort (n=30 evaluable), subjects are randomized 1:2 to either control (standard intraop opioid) or methadone HCl (0.3 mg/kg ideal body weight, IBW). Subjects in the study groups will receive methadone (IV bolus, after induction of anesthesia) as their primary intraoperative opioid, rather than leaving the choice of intraoperative opioid to the anesthesiologist. Intraoperative breakthrough pain will be treated at the discretion of the anesthesiologist with fentanyl. In the control groups, intraoperative opioid administration will be left at the discretion of the anesthesia providers. Patient controlled analgesia as prescribed by the clinical team, using hydromorphone or morphine, will be used to treat postoperative pain relief.

Interventions

  • Drug: 0.3mg/kg IV methadone HCl
    • Group I will receive 0.3mg/kg IV methadone HCl
  • Drug: 0.4mg/kg IV methadon HCl
    • Group II will receive 0.4mg/kg IV methadone HCl.
  • Other: control no methadone
    • The control group will not receive methadone.

Arms, Groups and Cohorts

  • Experimental: methadone HCl 0.3 mg/kg
    • 0.3mg/kg IV methadone HCl
  • Experimental: methadone HCl 0.4 mg/kg
    • 0.4mg/kg IV methadon HCl
  • Active Comparator: control group
    • control no methadone, standard of care opioids.

Clinical Trial Outcome Measures

Primary Measures

  • Total Opioid Consumption (Morphine Equivalent)
    • Time Frame: 6 days
    • Measure of overall morphine consumption
  • Pain Scores
    • Time Frame: 6 days
    • Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .

Secondary Measures

  • Cmax of R and S Methadone
    • Time Frame: 96 hours
    • Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.

Participating in This Clinical Trial

Inclusion Criteria.

  • Age 11-18 years – Undergoing general anesthesia and idiopathic posterior spinal surgery with anticipated postop inpatient stay of > 3 days – Signed, written, informed consent from legal guardians and assent from patient Exclusion Criteria. – History of or known liver or kidney disease. – Females who are pregnant or nursing. – Children with developmental delay – Children undergoing surgery for scoliosis of musculoskeletal origin

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anshuman Sharma, MD, Principal Investigator, Washington University School of Medicine

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