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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Scoliosis, Pain

Intervention / Treatment
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* Drug: Methadone
* Other: Normal Saline
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methadone, Gabapentin, Postoperative Pain, Posterior Spinal Fusion, Pediatric