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

NCT02558010 | Completed Phase 3 Results

• 1 other identifier: CHW-Methadone-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Pain

Keywords

Methadone; Gabapentin; Postoperative Pain; Posterior Spinal Fusion; Pediatric

Outcome Measures

Primary Outcomes (1)

• Post-operative Opioid Consumption (mg/kg)

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

  72 hours

Study Arms (2)

Methadone Group

EXPERIMENTAL

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; Drug: Morphine

Control Group

ACTIVE COMPARATOR

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

Other: Normal Saline; Drug: Morphine

Interventions

Methadone DRUG

Perioperative IV methadone to be given

Also known as: generic methadone

Methadone Group

Normal Saline OTHER

control arm

Also known as: salt water

Control Group

Morphine DRUG

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

Also known as: Duramorph

Control Group; Methadone Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 10-18 years
• Idiopathic scoliosis
• Fusion levels planned for 10 or greater
• English speaking
• American Society of Anesthesiology (ASA) class 1 - 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (4)

• 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.

  PMID: 2066846 BACKGROUND

• 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.

  PMID: 20418538 BACKGROUND

• 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.

  PMID: 20418301 BACKGROUND

• 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.

  PMID: 22037641 BACKGROUND

MeSH Terms

Conditions

Scoliosis; Pain; Pain, Postoperative

Interventions

Methadone; Saline Solution; Fluoridation; Morphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Preventive Dentistry; Dentistry; Public Health Dentistry; Environment and Public Health; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Keri R. Hainsworth, PhD
• Organization: Medical College of Wisconsin

khainswo@mcw.edu

414-266-6306

Study Officials

• Steven Weisman, MD

  Children's Hospital and Health System Foundation, Wisconsin

  STUDY CHAIR

• Roger A Fons, MD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: September 23, 2015
• Study Start: February 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: November 18, 2023
• Results First Posted: April 27, 2023

Record last verified: 2023-11

Locations

US (1)