Phase 3
N=58
Perioperative Methadone Use to Decrease Opioid Requirement in Pediatric Spinal Fusion Patients
Scoliosis · Pain
Bottom Line
View on ClinicalTrials.gov: NCT02558010 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Post-operative Opioid Consumption (mg/kg) — 0.267; 0.340 mg/kg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methadone (Drug); Normal Saline (Other); Morphine (Drug)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Opioid Consumption (mg/kg) |
0.267; 0.340 | <0.05 sig |
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.
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
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.