Preemptive Genotyping and Pain Management

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Pain

Treatments: Procedure: Preemptive genotyping in medical record; Procedure: Genotyping not included in electronic medical record

Study type: Observational

Funder types: Other

Identifiers

NCT01813695

NIH 3U01 HG006828-01S1 (Other Grant/Funding Number)

2013-0853

Details and patient eligibility

About

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.

Full 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.

Enrollment: 576 patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

576 participants in 2 patient groups

Preemptive

Description:

Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.

Treatment:

Procedure: Preemptive genotyping in medical record

Control

Description:

Genetic sample taken but withheld from electronic medical record.

Treatment:

Procedure: Genotyping not included in electronic medical record