Status:
ACTIVE_NOT_RECRUITING
Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Pain, Postoperative
Excavatum, Pectus
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, posto...
Detailed Description
This study will be a clinical prospective study. It is observational for all aims except with regard to the Meditation Intervention, which will be limited to 100 pectus and 100 spine participants (ran...
Eligibility Criteria
Inclusion
- Children aged 8 years of age through adulthood
- Diagnosis of pectus excavatum or adolescent idiopathic scoliosis
- Scheduled for endoscopic pectus excavatum repair or spine fusion
Exclusion
- History of or active renal or liver disease
- Major surgery requiring opioids in the last 5 years
- Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
- Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
- History of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included)
- Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine
- Needing postoperative ventilation or intraoperative cardiac bypass standby
- BMI \>35
- Pregnant or breastfeeding females
- Non-English speaking
- Definite developmental delay
Key Trial Info
Start Date :
July 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04031716
Start Date
July 6 2018
End Date
December 31 2025
Last Update
June 13 2025
Active Locations (1)
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1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229