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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558010
• Other study ID #: CHW-Methadone-001
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2016
• Est. completion date: January 1, 2023

Study information

• Verified date: November 2023
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Scoliosis

Intervention

Drug:
• Methadone
Perioperative IV methadone to be given

Other:
• Normal Saline
control arm

Drug:
• Morphine
Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.

Locations

Country	Name	City	State
United States	Children's Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Opioid Consumption (mg/kg)	Total amount of opioids consumed during the first 72 hours after surgery.	72 hours