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

Primary Purpose

Scoliosis, Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Methadone
Normal Saline
Morphine
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Methadone, Gabapentin, Postoperative Pain, Posterior Spinal Fusion, Pediatric

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 abuse
  • Morphine, hydromorphone or methadone allergies
  • Pregnancy
  • Seizure Disorders
  • Bleeding disorders
  • Neuromuscular scoliosis
  • Non-English speaking

Sites / Locations

  • Children's Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methadone Group

Control Group

Arm Description

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.

Patient will receive normal saline placebo initially, then morphine prior to emergence.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 13, 2015
Last Updated
April 25, 2023
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT02558010
Brief Title
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Official Title
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Pain
Keywords
Methadone, Gabapentin, Postoperative Pain, Posterior Spinal Fusion, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methadone Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patient will receive normal saline placebo initially, then morphine prior to emergence.
Intervention Type
Drug
Intervention Name(s)
Methadone
Other Intervention Name(s)
generic methadone
Intervention Description
Perioperative IV methadone to be given
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
salt water
Intervention Description
control arm
Intervention Type
Drug
Intervention Name(s)
Morphine
Other Intervention Name(s)
Duramorph
Intervention Description
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
Primary Outcome Measure Information:
Title
Post-operative Opioid Consumption (mg/kg)
Description
Total amount of opioids consumed during the first 72 hours after surgery.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 abuse Morphine, hydromorphone or methadone allergies Pregnancy Seizure Disorders Bleeding disorders Neuromuscular scoliosis Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Weisman, MD
Organizational Affiliation
Children's Hospital and Health System Foundation, Wisconsin
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Roger A Fons, MD
Organizational Affiliation
Children's Hospital and Health System Foundation, Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2066846
Citation
Berde CB, Beyer JE, Bournaki MC, Levin CR, Sethna NF. Comparison of morphine and methadone for prevention of postoperative pain in 3- to 7-year-old children. J Pediatr. 1991 Jul;119(1 Pt 1):136-41. doi: 10.1016/s0022-3476(05)81054-6.
Results Reference
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PubMed Identifier
20418538
Citation
Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
Results Reference
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PubMed Identifier
20418301
Citation
Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
Results Reference
background
PubMed Identifier
22037641
Citation
Sharma A, Tallchief D, Blood J, Kim T, London A, Kharasch ED. Perioperative pharmacokinetics of methadone in adolescents. Anesthesiology. 2011 Dec;115(6):1153-61. doi: 10.1097/ALN.0b013e318238fec5.
Results Reference
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Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients

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