Phase 3 Completed N=58 Randomized Quadruple-blind Treatment

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

scoliosis · Postoperative Pain

Source: ClinicalTrials.gov NCT02558010 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcomePrimary: Post-operative Opioid Consumption (mg/kg) — 0.267; 0.340 mg/kg — p=<0.05

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-operative Opioid Consumption (mg/kg)	0.267; 0.340	<0.05 sig

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02558010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.