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

Completed · Phase 3

Conditions studied: Scoliosis, Pain

In brief

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.

Key facts

Study ID

NCT02558010

Run by

Medical College of Wisconsin

People needed

58

Starts

2016-02-01

Expected to finish

2023-01-01

Last updated by the study team

2023-11-18

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Children's Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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