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

November 16, 2023 updated by: Keri Hainsworth, Medical College of Wisconsin

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Children's Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methadone Group
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.
Drug: Methadone
Perioperative IV methadone to be given
Other Names:
  • generic methadone
Drug: Morphine
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Other Names:
  • Duramorph
Active Comparator: Control Group
Patient will receive normal saline placebo initially, then morphine prior to emergence.
Drug: Morphine
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Other Names:
  • Duramorph
Other: Normal Saline
control arm
Other Names:
  • salt water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Opioid Consumption (mg/kg)
Time Frame: 72 hours
Total amount of opioids consumed during the first 72 hours after surgery.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Itching as assessed by number of doses of benadryl required post-operatively
Time Frame: 72 Hours
Number of doses benadryl per patient over 3 post-op days
72 Hours
Patient satisfaction as assessed by the question "How satisfied were you with your pain management?"
Time Frame: 72 hours
Responses can range from 0 (very dissatisfied) to 10 (very satisfied)
72 hours
Nausea as assessed by number of doses of ondansetron required post-operatively
Time Frame: 72 hours
Number of doses ondansetron per patient over 3 post-op days
72 hours
Constipation as assessed by number of days to first bowel movement
Time Frame: 72 hours
Number of days to first bowel movement will be recorded for each patient
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Study Chair: Steven Weisman, MD, Children's Hospital and Health System Foundation, Wisconsin
  • Principal Investigator: Roger A Fons, MD, Children's Hospital and Health System Foundation, Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimated)

September 23, 2015

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW-Methadone-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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