Phase 4
N=74
A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery
Thoracolumbar Scoliosis
Bottom Line
View on ClinicalTrials.gov: NCT02206685 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Opioid Usage — 0.41; 0.47; 0.58; 0.55 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone (Drug); Normal Saline (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Usage |
0.41; 0.47; 0.58; 0.55; 0.58; 0.55 | — |
| SECONDARY Pain Scores |
0.53; 0.65; 0.14; 0.42; 0.24; 0.36 | — |
Summary
Scoliosis is a disease that involves lateral and/or rotational deformity of the spine and can affect up to 4% of the population. Typically, surgery is considered when Cobb's angle, which is a measurement used for evaluation of curves in scoliosis on an anterior-posterior radiographic projection of the spine, is greater than 50 degrees in the thoracic region (40 degrees in the lumbar region) or when the curvature causes significant pain, or respiratory and cardiovascular restriction. Patient undergoing this surgical correction experience severe pain in the postoperative period and the management includes the use of opioid-based patient-controlled analgesia (PCA).
Eligibility Criteria
Inclusion Criteria
- Patient age 10 - 17 years
- Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and fusion
Exclusion Criteria
- Preoperative methadone therapy
- Inability to use the PCA
- Allergy to methadone or morphine
- Morbid obesity with a body mass index >36.0 kg/m2
- Patients with chronic renal failure defined by serum creatinine >2.0 mg/dL
- Liver failure defined as a history of cirrhosis or fulminant hepatic failure
- Preoperative congenital heart disease or arrhythmias
- Patient refusal to participate in study
- Pregnancy (It is standard of care for all post menarche female patients to undergo a urine pregnancy test prior to surgery).
Data sourced from ClinicalTrials.gov (NCT02206685). 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.