Methadone in Pediatric Anesthesiology II (MEPAII)

Methadone in Pediatric Anesthesia II

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).

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: 0.3mg/kg IV methadone HCl; Drug: 0.4mg/kg IV methadon HCl; Other: control no methadone

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: methadone HCl 0.3 mg/kg; 0.3mg/kg IV methadone HCl	Drug: 0.3mg/kg IV methadone HCl; Group I will receive 0.3mg/kg IV methadone HCl; Other Names: methadone HCl, dolophine
EXPERIMENTAL: methadone HCl 0.4 mg/kg; 0.4mg/kg IV methadon HCl	Drug: 0.4mg/kg IV methadon HCl; Group II will receive 0.4mg/kg IV methadone HCl.; Other Names: methadone HCl, dolophine
ACTIVE_COMPARATOR: control group; control no methadone, standard of care opioids.	Other: control no methadone; The control group will not receive methadone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption (Morphine Equivalent)	Measure of overall morphine consumption	6 days
Pain Scores	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 .	6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of R and S Methadone	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.	96 hours

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2013
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (ESTIMATE): November 21, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: spinal surgery; Methadone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone
• Other Study ID Numbers: 201302099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO