Status:
COMPLETED
A Trial Comparing Single Intra-op Dose of Methadone Versus Placebo in Patients Undergoing Spine Surgery
Lead Sponsor:
Baylor College of Medicine
Conditions:
Thoracolumbar Scoliosis
Eligibility:
All Genders
10-17 years
Phase:
PHASE4
Brief 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 measurem...
Detailed Description
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 measurem...
Eligibility Criteria
Inclusion
- Patient age 10 - 17 years
- Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and fusion
Exclusion
- 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).
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT02206685
Start Date
May 1 2014
End Date
January 27 2020
Last Update
February 16 2021
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030