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OpenTrials
Completed

NCT Number: NCT02558010

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

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Wisconsin

Milwaukee, Wisconsin, 53201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone

Drug

Perioperative IV methadone to be given

Other names: generic methadone

Normal Saline

Other

control arm

Other names: salt water

Morphine

Drug

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

Other names: Duramorph

Primary outcomes

  1. Post-operative Opioid Consumption (mg/kg)

    Time frame: 72 hours

    Total amount of opioids consumed during the first 72 hours after surgery.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Sep 23, 2015
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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