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| ID | Type | Description | Link |
|---|---|---|---|
| NIH 3U01 HG006828-01S1 | Other Grant/Funding Number | NIH Supplement Award |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preemptive | Patients with genotype testing entered into electronic medical record for consideration and opioid administration postoperatively. |
| |
| Control | Genetic sample taken but withheld from electronic medical record. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preemptive genotyping in medical record | Procedure |
| ||
| Genotyping not included in electronic medical record |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From initial clinic visit to post-operative discharge, expected average of three months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Admission for surgery, up to two weeks |
| Analgesia Toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Association between specific genotypes and pain sensitivity, reported postoperative pain, and opioid response | 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)) | Postoperative surgery, up to two weeks |
Inclusion Criteria:
Exclusion Criteria:
• Who had prior surgery for idiopathic scoliosis and/or pectus excavatum
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Pediatric patients scheduled for scoliosis and pectus excavatum surgeries.
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| Name | Affiliation | Role |
|---|---|---|
| Senthilkumar Sadhasivam, MD, MPH | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20006257 | Background | Sadhasivam S, Boat A, Mahmoud M. Comparison of patient-controlled analgesia with and without dexmedetomidine following spine surgery in children. J Clin Anesth. 2009 Nov;21(7):493-501. doi: 10.1016/j.jclinane.2008.12.017. | |
| 18635469 | Background | Voepel-Lewis T, Marinkovic A, Kostrzewa A, Tait AR, Malviya S. The prevalence of and risk factors for adverse events in children receiving patient-controlled analgesia by proxy or patient-controlled analgesia after surgery. Anesth Analg. 2008 Jul;107(1):70-5. doi: 10.1213/ane.0b013e318172fa9e. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D005660 | Funnel Chest |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001848 | Bone Diseases, Developmental |
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| ID | Term |
|---|---|
| D008499 | Medical Records |
| D057286 | Electronic Health Records |
| ID | Term |
|---|---|
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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Saliva Blood
| Procedure |
|
| Admission for surgery, up to two weeks |
| Analgesia Effectiveness | Participant related responses in "Pain Medicine Report" | Admission for surgery, up to two weeks |
| Analgesia Effectiveness | Total number of rescue IV pain medication doses | Admission for surgery, up to two weeks |
| Analgesia Effectiveness | Total number of concomitant analgesic adjunct medications such as muscle relaxants, acetaminophen. | Admission for surgery, up to two weeks |
| Analgesia Effectiveness | Total mg/kg 24hr dose of oral opioids | Admission for surgery, up to two weeks |
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| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D016347 | Medical Records Systems, Computerized |