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

Medical College of Wisconsin

Status and phase: Completed; Phase 3

Conditions: Scoliosis; Pain

Treatments: Other: Normal Saline; Drug: Morphine; Drug: Methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT02558010

CHW-Methadone-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

58 participants in 2 patient groups

Methadone Group

Experimental group

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.

Treatment:

Drug: Methadone

Drug: Morphine

Control Group

Active Comparator group

Description:

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

Treatment:

Drug: Morphine

Other: Normal Saline