CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Methadone +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02558010
NCT02558010Phase 3Completed

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

Medical College of Wisconsin·interventional·Posted Sep 23, 2015·Updated Nov 18, 2023

In Brief

A Phase 3 clinical trial evaluating Methadone, Normal Saline, and 1 other intervention for Scoliosis and Pain. Completed, enrolled 58 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsScoliosis, Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 23, 2015
Enrollment StartFeb 1, 2016
Primary CompletionJan 1, 2022
Study CompletionJan 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 10.8 years ago

Interventions

Methadonedrug

Perioperative IV methadone to be given

Normal Salineother

control arm

Morphinedrug

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