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

Phase 3

Completed

• Conditions: Pain; Scoliosis
• Interventions: Other: Normal Saline; Drug: Methadone; Drug: Morphine

• Registration Number: NCT02558010
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-09-22
• Study First Posted: 2015-09-23
• Study Start: 2016-02-01
• Primary Completion: 2022-01-01
• Study Completion: 2023-01-01
• Results First Submitted: 2023-04-05
• Results First Submitted QC: 2023-04-25
• Results First Posted: 2023-04-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 use disorder
• Morphine, hydromorphone or methadone allergies
• Pregnancy
• Seizure disorders
• Bleeding disorders
• Neuromuscular scoliosis
• History of renal or hepatic disease
• Long QT syndrome
• Obstructive sleep apnea
• Body mass index > 40
• Inability to tolerate standard analgesic medications (gabapentin, ketorolac, acetaminophen)
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	Normal Saline	Patient will receive normal saline placebo initially, then morphine prior to emergence.
Methadone Group	Methadone	Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.
Methadone Group	Morphine	Patients will receive a total of 0.2mg/kg IV methadone intraoperative (0.1mg / kg preincision and 0.1mg/kg prior to emergence) with a maximum dosing of 20 mg.
Control Group	Morphine	Patient will receive normal saline placebo initially, then morphine prior to emergence.

Primary Outcome Measures

Name	Time	Method
Post-operative Opioid Consumption (mg/kg)	72 hours	Total amount of opioids consumed during the first 72 hours after surgery.

Trial Locations

Locations (1)

Children's Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States