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Preemptive Genotyping and Pain Management

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01813695
First received: March 11, 2013
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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 Intervention
Pain
Procedure: Preemptive genotyping in medical record
Procedure: Genotyping not included in electronic medical record

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preemptive Genotyping of Children and Adolescents at Risk for Surgery and Subsequent Pain Management

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Feasibility of PreEmptive Genotyping Testing [ Time Frame: From initial clinic visit to post-operative discharge, expected average of three months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Admission for surgery, up to two weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Admission for surgery, up to two weeks ] [ Designated as safety issue: Yes ]
    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?"

  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ] [ Designated as safety issue: No ]
    Participant related responses in "Pain Medicine Report"

  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ] [ Designated as safety issue: No ]
    Total number of rescue IV pain medication doses

  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ] [ Designated as safety issue: No ]
    Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.

  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ] [ Designated as safety issue: No ]
    Total mg/kg 24hr dose of oral opioids


Other Outcome Measures:
  • Association between specific genotypes and pain sensitivity, reported postoperative pain, and opioid response [ Time Frame: Postoperative surgery, up to two weeks ] [ Designated as safety issue: No ]
    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))


Biospecimen Retention:   Samples With DNA

Saliva Blood


Estimated Enrollment: 748
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric patients scheduled for scoliosis and pectus excavatum surgeries.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813695

Contacts
Contact: Senthilkumar Sadhasivam, MD, MPH 513-636-4408 senthilkumar.sadhasivam@cchmc.org
Contact: Cynthia Prows 513-636-7963 cindy.prows@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Nicole Dalessandro    513-803-9285    Nicole.Dalessandro@cchmc.org   
Contact: Susan Glynn    (513) 636-7193      
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH Children's Hospital Medical Center, Cincinnati
  More Information

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01813695     History of Changes
Other Study ID Numbers: 2013-0853, NIH 3U01 HG006828-01S1
Study First Received: March 11, 2013
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Preemptive genetic testing
Pain
Pediatrics
Orthopedics
Pectus excavatum
Scoliosis

ClinicalTrials.gov processed this record on November 27, 2014