Preemptive Genotyping and Pain Management

Study Overview
=================
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.

Official Title
-----------------
Preemptive Genotyping of Children and Adolescents at Risk for Surgery and Subsequent Pain Management

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Preemptive genotyping in medical record
* Procedure: Genotyping not included in electronic medical record


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preemptive<br>Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively. | Procedure: Preemptive genotyping in medical record<br> <br> |
| Control<br>Genetic sample taken but withheld from electronic medical record. | Procedure: Genotyping not included in electronic medical record<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of PreEmptive Genotyping Testing | 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. | From initial clinic visit to post-operative discharge, expected average of three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Effectiveness | 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) | Admission for surgery, up to two weeks | 
| Analgesia Toxicity | At least 1 documented ADR; Total number of documented ADRs; Total number of ADR related responses in Pain Medicine Report answered sometimes or always; Total number of documented GI related ADRs - nausea (yes/no) and vomiting (yes/no); 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? | Admission for surgery, up to two weeks | 
| Analgesia Effectiveness | Participant related responses in Pain Medicine Report | Admission for surgery, up to two weeks | 
| Analgesia Effectiveness | Total number of rescue IV pain medication doses | Admission for surgery, up to two weeks | 
| Analgesia Effectiveness | Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen. | Admission for surgery, up to two weeks | 
| Analgesia Effectiveness | Total mg/kg 24hr dose of oral opioids | Admission for surgery, up to two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preemptive genetic testing, Pain, Pediatrics, Orthopedics, Pectus excavatum, Scoliosis