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.
Study Type
OBSERVATIONAL
Enrollment
576
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Feasibility of PreEmptive Genotyping Testing
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.
Time frame: From initial clinic visit to post-operative discharge, expected average of three months
Analgesia Effectiveness
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)
Time frame: Admission for surgery, up to two weeks
Analgesia Toxicity
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?"
Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Participant related responses in "Pain Medicine Report"
Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Total number of rescue IV pain medication doses
Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen.
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Time frame: Admission for surgery, up to two weeks
Analgesia Effectiveness
Total mg/kg 24hr dose of oral opioids
Time frame: Admission for surgery, up to two weeks