Preemptive Genotyping and Pain Management

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01813695

Collaborator

(none)

748

Enrollment

Location

117

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: Preemptive genotyping in medical record Procedure: Genotyping not included in electronic medical record

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 Design

Study Type:

Observational

Anticipated Enrollment :

748 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Nov 4, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Preemptive

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

Procedure: Preemptive genotyping in medical record

Control

Genetic sample taken but withheld from electronic medical record.

Procedure: Genotyping not included in electronic medical record

Outcome Measures

Primary Outcome Measures

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

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]
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?"
Analgesia Effectiveness [Admission for surgery, up to two weeks]
Participant related responses in "Pain Medicine Report"
Analgesia Effectiveness [Admission for surgery, up to two weeks]
Total number of rescue IV pain medication doses
Analgesia Effectiveness [Admission for surgery, up to two weeks]
Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.
Analgesia Effectiveness [Admission for surgery, up to two weeks]
Total mg/kg 24hr dose of oral opioids

Other Outcome Measures

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))

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 21 Years

Sexes Eligible for Study:

All

Accepts 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