NCT02558010

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Scoliosis
• Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2015-09-23
• Last updated: 2023-11-18
• Results posted: 2023-04-27

Locations

1 site across 1 country: United States