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Completed

NCT Number: NCT01813695

Preemptive Genotyping and 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.

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Key information

Conditions

Pain Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Scoliosis Signs and Symptoms Spinal Curvatures Spinal Diseases

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preemptive genotyping in medical record

Procedure

Genotyping not included in electronic medical record

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Analgesia Toxicity

    Time frame: 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?"

  3. Analgesia Effectiveness

    Time frame: Admission for surgery, up to two weeks

    Participant related responses in "Pain Medicine Report"

  4. Analgesia Effectiveness

    Time frame: Admission for surgery, up to two weeks

    Total number of rescue IV pain medication doses

  5. Analgesia Effectiveness

    Time frame: Admission for surgery, up to two weeks

    Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.

  6. Analgesia Effectiveness

    Time frame: Admission for surgery, up to two weeks

    Total mg/kg 24hr dose of oral opioids

Other outcomes

  1. 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))

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2022
First posted
Mar 19, 2013
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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