Methadone in Pediatric Anesthesiology II

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: 0.3mg/kg IV methadone HCl; Other: control no methadone; Drug: 0.4mg/kg IV methadon HCl

• Registration Number: NCT01990573
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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).

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 Timeline

• Study Start: 2013-04-10
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-20
• Study First Posted: 2013-11-21
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Results First Submitted: 2019-09-09
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-17
• Last Update Submitted: 2020-01-17
• Results First Posted: 2020-01-28
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methadone HCl 0.3 mg/kg	0.3mg/kg IV methadone HCl	0.3mg/kg IV methadone HCl
control group	control no methadone	control no methadone, standard of care opioids.
methadone HCl 0.4 mg/kg	0.4mg/kg IV methadon HCl	0.4mg/kg IV methadon HCl

Primary Outcome Measures

Name	Time	Method
Pain Scores	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 .
Total Opioid Consumption (Morphine Equivalent)	6 days	Measure of overall morphine consumption

Secondary Outcome Measures

Name	Time	Method
Cmax of R and S Methadone	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States