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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
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The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
This is a research study to find out what the side effects are of certain drugs that are commonly used for pain and to put people to sleep for surgery. The researchers also want to know how the drug is broken down in the body. Participants will be given these drugs as they are prescribed by their regular doctor. As part of the participant's standard of care, doctors will perform tests, ask questions, review medical information and measure vital signs (heart rate, blood pressure, etc). The researchers will collect information that doctors have already written in the medical records. The research study team will collect blood from participants at certain time points depending on when the participant was first given the drug (up to 5 samples over the course of 10 to 48 hours). Examples of current and upcoming anesthetics and analgesics include, but are not limited to: ketorolac (Toradol), ketamine (Ketalar), oxycodone (OxyContin), and morphine (Kadian, MS Contin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug of Interest | Individuals receiving anesthetics or analgesics per standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine | Drug | IV ketorolac will be given per standard of care, not prescribed for this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL) or apparent oral clearance (CL/F) | up to 48 hours post dose | |
| Volume of distribution (V) or apparent oral volume of distribution (V/F) | up to 48 hours post dose | |
| Elimination rate constant (ke) | up to 48 hrs post dose | |
| Half-life (t1/2) | up to 48 hrs post dose | |
| Absorption rate constant (ka) | up to 48 hrs post dose | |
| Area under the curve (AUC) | up to 48 hrs post dose | |
| Maximum concentration (CMAX) | up to 48 hrs post dose | |
| Time to achieve maximum concentration (TMAX) | up to 48 hrs post dose |
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Inclusion Criteria:
Exclusion Criteria:
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Approximately 60 participants will be enrolled to each of the study drug of interests (DOI) cohorts. Participants who satisfy eligibility criteria and are receiving one or more DOIs per standard of care will be consented into the study and assigned to the corresponding DOI cohort. DOI cohort assignments will be at the discretion of the treating physician based on the DOIs that are administered per standard of care. Participants will be selected from a variety of centers including but not limited to trauma and intensive care units. Participants will not be randomized. Participants may count towards 1 or more DOIs within the same 90-day period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kady-Ann Steen-Burrell, PhD | Contact | 919-530-9711 | kady.ann.steen.burrell@duke.edu | |
| Cheryl Alderman | Contact | 919-668-8349 | cheryl.alderman@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chi Hornik, PharmD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Active, not recruiting | Stanford | California | 94305 | United States | |
All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
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Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.
In order to have access, researchers have to complete a Data access request. NICHD will review the request and either approve or deny it. IRB approval must be obtained by the researcher to access the data.
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D004091 | Hydromorphone |
| D007649 | Ketamine |
| D010098 | Oxycodone |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Left over specimens will be de-identified and sent to the NICHD biorepository at the end of the study. These specimens may be made available to other researchers. Future unspecified tests conducted may include genetic testing.
| Hydromorphone | Drug | IV Hydromorphone will be given per standard of care, not prescribed for this study |
|
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| Ketamine | Drug | IV Ketamine will be given per standard of care, not prescribed for this study |
|
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| Oxycodone | Drug | PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study |
|
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| Morphine | Drug | IV Morphine will be given per standard of care, not prescribed for this study |
|
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| Children's Hospital Colorado |
| Terminated |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Alfred I. DuPont Hospital for Children | Active, not recruiting | Wilmington | Delaware | 19803 | United States |
| Ann and Robert H. Lurie Childrens Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
|
| Cardinal Glennon Children's Hospital | Active, not recruiting | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | Active, not recruiting | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27701 | United States |
|
| Oregon Health and Science University | Active, not recruiting | Portland | Oregon | 97239 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
|
| Dell Children's Medical Center of Texas | Withdrawn | Austin | Texas | 78723 | United States |
| Baylor College of Medicine | Withdrawn | Houston | Texas | 77030 | United States |
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
|
| Hospital Sainte-Justine | Active, not recruiting | Montreal | Quebec | T3T 1C5 | Canada |
| D006571 | Heterocyclic Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D003061 | Codeine |