Milwaukee, Wisconsin 53201


Purpose:

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.


Study summary:

This study is a double blind comparison, evaluating the benefits of intraoperative methadone in extensive posterior spine fusion surgery for idiopathic scoliosis. Methadone 0.2 mg/kg will be given to the treatment group. Postoperative evaluation for narcotic use, pain control, and adverse effects will be compared to a standard treatment approach used at Children's Hospital of Wisconsin.


Criteria:

Inclusion Criteria: - Age 10-18 years - Idiopathic scoliosis - Fusion levels planned for 10 or greater - English speaking - American Society of Anesthesiology (ASA) class 1 - 3 Exclusion Criteria: - Current narcotic use / History of substance abuse - Morphine, hydromorphone or methadone allergies - Pregnancy - Seizure Disorders - Bleeding disorders - Non-English speaking


NCT ID:

NCT02558010


Primary Contact:

Study Chair
Steven Weisman, MD
Children's Hospital and Health System Foundation, Wisconsin

Keri Hainsworth, PhD
Phone: 414266-6306
Email: khainsworth@chw.org


Backup Contact:

Email: eedwards@mcw.edu
Ellen Edwards, BS


Location Contact:

Milwaukee, Wisconsin 53201
United States

Roger A Fons, MD
Phone: 414-266-3561
Email: rfons@mcw.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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