Preemptive Genotyping and Pain Management

February 21, 2024 updated by: Children's Hospital Medical Center, Cincinnati

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

576

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients scheduled for scoliosis and pectus excavatum surgeries.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between specific genotypes and pain sensitivity, reported postoperative pain, and opioid response
Time Frame: 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))
Postoperative surgery, up to two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Senthilkumar Sadhasivam, MD, MPH, Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 4, 2020

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

March 11, 2013

First Submitted That Met QC Criteria

March 15, 2013

First Posted (Estimated)

March 19, 2013

Study Record Updates

Last Update Posted (Actual)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-0853
  • NIH 3U01 HG006828-01S1 (Other Grant/Funding Number: NIH Supplement Award)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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