At a glance
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A Randomized Blinded Prospective Trial Comparing Single Intraoperative Dose of Methadone Versus Placebo in Pediatric Patients Undergoing Spine Surgery.
In Brief
A Phase 4 clinical trial evaluating Methadone and Normal Saline for Thoracolumbar Scoliosis. Completed, enrolled 74 participants across 1 site.
Detailed Summary
Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which is a measurement used for evaluation of curves in scoliosis on an anterior-posterior radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40 degrees in the lumbar region) or when the curvature causes significant pain, or respiratory and cardiovascular restriction. Patient undergoing this surgical correction experience severe pain in the postoperative period and the management includes the use of opioid-based patient-controlled analgesia (PCA).
Study Details
Timeline
Interventions
The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
the control group will receive a 20 ml normal saline placebo infusion over 10 minutes