An observational study in Anesthesia and Pain, sponsored by Chi Dang Hornik. Recruiting at 13 sites in 2 countries. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Chi Dang Hornik · Observational
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).
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 551 is above the median of 100 across 1,252 observational studies indexed under Pain.
Browse Pain studies →Chi Dang Hornik is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
Approximately 100 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals receiving anesthetics or analgesics per standard of care
Drug: Ketorolac Tromethamine · Drug: Hydromorphone · Drug: Ketamine · Drug: Oxycodone · Drug: Morphine · Drug: Fentanyl (IV)
IV ketorolac will be given per standard of care, not prescribed for this study
Also known as: Toradol
IV Hydromorphone will be given per standard of care, not prescribed for this study
Also known as: Hydromorphone hydrochloride, Dilaudid
IV Ketamine will be given per standard of care, not prescribed for this study
Also known as: Ketamine Hydrochloride
PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study
Also known as: Oxycodone Hydrochloride
IV Morphine will be given per standard of care, not prescribed for this study
Also known as: Morphine Sulfate
Fentanyl IV will be administered intravenously or intramuscularly per standard of care, not prescribed for this study
Also known as: Fentanyl Citrate
Clearance (CL) or apparent oral clearance (CL/F)
Time frame: up to 48 hours post dose
Volume of distribution (V) or apparent oral volume of distribution (V/F)
Time frame: up to 48 hours post dose
Elimination rate constant (ke)
Time frame: up to 48 hrs post dose
Half-life (t1/2)
Time frame: up to 48 hrs post dose
Absorption rate constant (ka)
Time frame: up to 48 hrs post dose
Area under the curve (AUC)
Time frame: up to 48 hrs post dose
Maximum concentration (CMAX)
Time frame: up to 48 hrs post dose
Time to achieve maximum concentration (TMAX)
Time frame: up to 48 hrs post dose
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes — All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
Time frame: Data will be uploaded to the repository within 2 years of study completion. It will be maintained in the repository indefinitely.
Access criteria: 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. https://dash.nichd.nih.gov/Resource/DataRequestChecklist
Data sharing details ↗ · dash.nichd.nih.gov
No publications or documents are linked to this record.
Started Dec 2018 (actual). Primary completion is estimated for Aug 2027, 104 months after the start.
Of 504 non-industry observational studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 104 months is above that.
Counting every sponsor, half of 519 studies reached it within 18 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Chi Dang Hornik