Status:
COMPLETED
Preemptive Genotyping and Pain Management
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Pain
Eligibility:
All Genders
6-21 years
Brief Summary
The purpose of this study is to see if testing for genes related to pain and pain management before surgery affects how patients are treated for pain after surgery. The investigators want to know if t...
Detailed Description
Purpose: To determine the feasibility of preemptive (preoperative) cytochrome P450 isoenzyme (CYP2D6) testing and the variability of clinical measures (postoperative) in children whose opioid selectio...
Eligibility Criteria
Inclusion
- Children, 6-17 years of age and adults, 18 - 21 years with idiopathic scoliosis and/or pectus excavatum scheduled for surgical clinic visit
- BMI \< 30
- Cognitively able to use a 0 - 10 numerical rating scale (NRS) to report level of pain
- Parents give permission (and children give assent when appropriate) or adult participants give consent for CYP2D6 results to be placed in Cincinnati Children's Hospital Medical Center (CCHMC's) EPIC
Exclusion
- • Who had prior surgery for idiopathic scoliosis and/or pectus excavatum
- Who have prior CYP2D6 testing or Genetic Pharmacology Service (GPS) Psychiatry Panel documented in EPIC
- Who are taking prescription medication known to inhibit or induce CYP2D6
- Who are taking prescription medication known to inhibit (e.g. voriconazole) or induce (e.g. carbamazepine and rifampin) CYP3A4
- Who have liver or renal failure
- Who have history of narcotic abuse
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT01813695
Start Date
March 1 2013
End Date
December 30 2022
Last Update
February 22 2024
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229