Overview

This trial is active, not recruiting.

Condition pain
Treatments preemptive genotyping in medical record, genotyping not included in electronic medical record
Sponsor Children's Hospital Medical Center, Cincinnati
Start date March 2013
End date March 2019
Trial size 748 participants
Trial identifier NCT01813695, 2013-0853, NIH 3U01 HG006828-01S1

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 this information will be used to effectively treat patients for pain after surgery if the clinical staff have a chance to review it before the surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.
preemptive genotyping in medical record
Genetic sample taken but withheld from electronic medical record.
genotyping not included in electronic medical record

Primary Outcomes

Measure
Feasibility of PreEmptive Genotyping Testing
time frame: From initial clinic visit to post-operative discharge, expected average of three months

Secondary Outcomes

Measure
Analgesia Effectiveness
time frame: Admission for surgery, up to two weeks
Analgesia Toxicity
time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
time frame: Admission for surgery, up to two weeks

Eligibility Criteria

Male or female participants from 6 years up to 21 years old.

Inclusion Criteria: - 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 Criteria: - • 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

Additional Information

Official title Preemptive Genotyping of Children and Adolescents at Risk for Surgery and Subsequent Pain Management
Principal investigator Senthilkumar Sadhasivam, MD, MPH
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 selection and dosing is influenced by preemptive CYP2D6 testing compared to children whose pain management does not include CYP2D6 preemptive testing. Results from this pilot study will inform a future study investigating the utility of preemptive pharmacogenomic testing in children at risk for requiring inpatient acute pain management with opioids.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.