Pain
Conditions
Keywords
Preemptive genetic testing, Pain, Pediatrics, Orthopedics, Pectus excavatum, Scoliosis
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 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.
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 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.
Interventions
PROCEDUREPreemptive genotyping in medical record
PROCEDUREGenotyping not included in electronic medical record
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of PreEmptive Genotyping Testing | From initial clinic visit to post-operative discharge, expected average of three months | The Investigator will use descriptive and summary statistics to determine the feasibility of preemptive CYP2D6 testing in children evaluated during a clinic visit for potential surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia Effectiveness | Admission for surgery, up to two weeks | Pain score (NRS 0 - 10) before and after each oral opioid dose (we will use time between the before and after pain score measures as a covariate) |
| Analgesia Toxicity | Admission for surgery, up to two weeks | 1. At least 1 documented ADR; 2. Total number of documented ADRs; 3. Total number of ADR related responses in Pain Medicine Report answered sometimes or always; 4. Total number of documented GI related ADRs - nausea (yes/no) and vomiting (yes/no); 5. Total number of documented central nervous system (CNS) ADRs (Modified Ramsay scores \> 4 and respiratory rate (RR) indicative of respiratory depression; and oxygen saturations (SpO2) \< 90% on room air; and need for supplemental oxygen; and response of always for Pain Medicine Report question, When you took the pain medicine, how often did it make you fall asleep? |
Other
| Measure | Time frame | Description |
|---|---|---|
| Association between specific genotypes and pain sensitivity, reported postoperative pain, and opioid response | Postoperative surgery, up to two weeks | To explore association between specific genotypes (in addition to CYP2D6) and pain sensitivity, reported postoperative pain, and opioid response (pain reduction and incidence of adverse drug reactions (ADRs)) |
Countries
United States
Outcome results
None listed