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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2023-01-01

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.

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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.

Conditions

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Scoliosis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Methadone

Intervention Type DRUG

Perioperative IV methadone to be given

Morphine

Intervention Type DRUG

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

Control Group

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

Group Type ACTIVE_COMPARATOR

Normal Saline

Intervention Type OTHER

control arm

Morphine

Intervention Type DRUG

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

Interventions

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Methadone

Perioperative IV methadone to be given

Intervention Type DRUG

Normal Saline

control arm

Intervention Type OTHER

Morphine

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

Intervention Type DRUG

Other Intervention Names

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generic methadone salt water Duramorph

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No