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Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients

NCT02558010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-11-18

Study results available
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Summary

Acute pain management following major surgical procedures in pediatric patients continues to be a challenge, especially after extensive posterior spine fusions.

Spine surgery is particularly traumatic, initiating pain in both peripheral and central pathways. While the standard management of post-surgical pain involves a multimodal approach, opioids provide the predominant benefit. However, opioid use is associated with many adverse effects, including nausea, constipation, and pruritus. Perioperative methadone may decrease total opioid consumption and adverse effects as well as improve satisfaction with pain management after scoliosis repair.

Conditions

Interventions

DRUG

Methadone

Perioperative IV methadone to be given

OTHER

Normal Saline

control arm

DRUG

Morphine

Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Steven Weisman, MD · Children's Hospital and Health System Foundation, Wisconsin

  • Roger A Fons, MD · Children's Hospital and Health System Foundation, Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2022-01-01
Completion
2023-01-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02558010 on ClinicalTrials.gov