Preemptive Genotyping and Pain Management

Completed

• Conditions: Pain
• Interventions: Procedure: Preemptive genotyping in medical record; Procedure: Genotyping not included in electronic medical record

• Registration Number: NCT01813695
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-15
• Study First Posted: 2013-03-19
• Primary Completion: 2020-11-04
• Study Completion: 2022-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preemptive	Preemptive genotyping in medical record	Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.
Control	Genotyping not included in electronic medical record	Genetic sample taken but withheld from electronic medical record.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Analgesia Effectiveness	Admission for surgery, up to two weeks	Total mg/kg 24hr dose of oral opioids
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?"

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States