drugset / Trial / NCT02558010

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

NCT02558010 ↗

Phase 3 Completed 58 enrolled Medical College of Wisconsin
RandomizedSingle-groupQuadruple-blindTreatment

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.

Timeline

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

Outcome

Met primary endpoint

registry MEDIAN Methadone Group: 0.267 (0.119 to 0.451) mg/kg MEDIAN Control Group: 0.340 (0.168 to 0.607) mg/kg NCT02558010 ↗

registry analysis (superiority test); Methadone Group vs Control Group; p <0.05; Mixed Models Analysis NCT02558010 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methadone Other / unclassified 0.2 mg/kg Intravenous
Background Morphine Other / unclassified — —

Indications