ClinicalTrials.gov
ClinicalTrials.gov Menu

Preemptive Genotyping and Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01813695
Recruitment Status : Active, not recruiting
First Posted : March 19, 2013
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

March 11, 2013
March 19, 2013
February 5, 2016
March 2013
March 2019   (Final data collection date for primary outcome measure)
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.
Feasibility of Pre-Emptive 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 pre-emptive CYP2D6 testing in children evaluated during a clinic visit for potential surgery.
Complete list of historical versions of study NCT01813695 on ClinicalTrials.gov Archive Site
  • 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)
  • 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?"
  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]
    Participant related responses in "Pain Medicine Report"
  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]
    Total number of rescue IV pain medication doses
  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]
    Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.
  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]
    Total mg/kg 24hr dose of oral opioids
  • Analgesia Effectiveness [ Time Frame: Admission for surgery, up to two weeks ]
    1. 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. Participant related responses in "Pain Medicine Report";
    3. Total mg/kg 24hr dose of oral opioids;
    4. Total number of rescue IV pain medication doses; and
    5. Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.
  • 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 CNS ADRs (Modified Ramsay scores > 4 and RR indicative of respiratory depression; and SpO2 saturations < 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?"
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))
Same as current
 
Preemptive Genotyping and Pain Management
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Saliva Blood
Non-Probability Sample
Pediatric patients scheduled for scoliosis and pectus excavatum surgeries.
Pain
  • Procedure: Preemptive genotyping in medical record
  • Procedure: Genotyping not included in electronic medical record
  • Preemptive
    Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.
    Intervention: Procedure: Preemptive genotyping in medical record
  • Control
    Genetic sample taken but withheld from electronic medical record.
    Intervention: Procedure: Genotyping not included in electronic medical record

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
748
Same as current
April 2021
March 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01813695
2013-0853
NIH 3U01 HG006828-01S1 ( Other Grant/Funding Number: NIH Supplement Award )
No
Not Provided
Not Provided
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
February 2016