Preemptive Genotyping and Pain Management
Recruitment status was Not yet recruiting
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.
Procedure: Preemptive genotyping in medical record
Procedure: Genotyping not included in electronic medical record
|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|
- 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.
- 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 ]
- 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?"
- 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
- 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
|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)|
Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively.
|Procedure: Preemptive genotyping in medical record|
Genetic sample taken but withheld from electronic medical record.
|Procedure: Genotyping not included in electronic medical record|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01813695
|Contact: Senthilkumar Sadhasivam, MD, MPHfirstname.lastname@example.org|
|Contact: Cynthia Prowsemail@example.com|
|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|
|Principal Investigator:||Senthilkumar Sadhasivam, MD, MPH||Children's Hospital Medical Center, Cincinnati|