AnesthesiaANA01NCT03427736
Anesthetics and Analgesics in Children
An observational study of Anesthesia and Pain, run by Chi Dang Hornik at 13 sites in 2 countries.
Trial summary
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents. Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Anesthesia, Pain
- What is being tested?
- Ketorolac Tromethamine, Hydromorphone and Ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 551 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 13 Dec 2018to 9 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 6 months to <18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range)
- Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
- Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
- Receiving one or more drugs of interest (DOI) per local standard of care
- Meeting DOI-specific inclusion criteria (See Appendices)
Who cannot join
- Known pregnancy
- Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
United States11 sites, 5 recruiting
- Terminated
Children's Hospital Colorado
Aurora, Colorado, 80045
- Withdrawn
Dell Children's Medical Center of Texas
Austin, Texas, 78723
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
John Costello, MD, 843-792-9570, costello@musc.edu
Mary Freeman, 843-792-5762, freemanme@musc.edu
- Recruiting
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
Amy Fang, MD, 1-312-227-4448, zafang@luriechildrens.org
Richa Mehta, 1-312-227-4448, rmehta@luriechildrens.org
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27701
Melissa Harward, (919) 668-3910, Melissa.Harward@duke.edu
Chi Hornik, 919.970.6680, chi.dang@duke.edu
- Withdrawn
Baylor College of Medicine
Houston, Texas, 77030
- Active, not recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Active, not recruiting
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
- Terminated
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Lucile Packard Children's Hospital
Stanford, California, 94305
Radhamangalam Ramamurthi, rjram@stanford.edu
Jyoti Bhamidipati, jyotib@stanford.edu
- Recruiting
Alfred I. DuPont Hospital for Children
Wilmington, Delaware, 19803
Marisa Meyer, DO, 1-302-651-4021, marisa.meyer@nemours.org
Gwen Pellicciotti, RN, BSN, 1-484-824-4902, gwen.pellicciotti@nemours.org
Canada2 sites, 2 recruiting
- Recruiting
Hospital Sainte-Justine
Montreal, Quebec, T3T 1C5
Julie Autmizguine, 1-514-345-4931, julie.autmizguine@umontreal.ca
Clotilde Gravel, 1-514-345-4931, clotilde.gravel.hsj@ssss.gouv.qc.ca
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Yaron Finkelstein, 1-416-813-5317, yaron.finkelstein@sickkids.ca
Maggie Rumantir, 1-416-813-7654, maggie.rumantir@sickkids.ca
About this study
Official title: Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
Read the detailed description
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).
- Conditions
- Anesthesia, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Also called Toradol
IV ketorolac will be given per standard of care, not prescribed for this study
HydromorphoneDrug
Also called Hydromorphone hydrochloride, Dilaudid
IV Hydromorphone will be given per standard of care, not prescribed for this study
KetamineDrug
Also called Ketamine Hydrochloride
IV Ketamine will be given per standard of care, not prescribed for this study
OxycodoneDrug
Also called Oxycodone Hydrochloride
PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study
MorphineDrug
Also called Morphine Sulfate
IV Morphine will be given per standard of care, not prescribed for this study
Fentanyl (IV)Drug
Also called Fentanyl Citrate
Fentanyl IV will be administered intravenously or intramuscularly per standard of care, not prescribed for this study
| Study group | Role | What they receive |
|---|---|---|
| Drug of Interest | Individuals receiving anesthetics or analgesics per standard of care Receives: Drug: Ketorolac Tromethamine; Drug: Hydromorphone; Drug: Ketamine; Drug: Oxycodone; Drug: Morphine; Drug: Fentanyl (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance (CL) or apparent oral clearance (CL/F)
Measured: up to 48 hours post dose
Volume of distribution (V) or apparent oral volume of distribution (V/F)
Measured: up to 48 hours post dose
Elimination rate constant (ke)
Measured: up to 48 hrs post dose
Half-life (t1/2)
Measured: up to 48 hrs post dose
Absorption rate constant (ka)
Measured: up to 48 hrs post dose
Area under the curve (AUC)
Measured: up to 48 hrs post dose
Maximum concentration (CMAX)
Measured: up to 48 hrs post dose
Time to achieve maximum concentration (TMAX)
Measured: up to 48 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start13 Dec 2018
- Primary completion30 Aug 2027 (estimated)
- Study completion9 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 551 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi Dang Hornik
- Sponsor type
- University, hospital or other
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, Chi Dang Hornik, Duke University
- Investigators
- Chi Hornik, PharmD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427736
- Sponsor's protocol ID
- Pro00088893
- Acronym
- ANA01
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected is uploaded into the National Institute of Health Data Repository (DASH) at the end of the study (de-identified).
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent
- ClinicalTrials.gov ID
- NCT03427736
- Acronym / sponsor ID
- ANA01 / Pro00088893
- Conditions
- Anesthesia, Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 551 participants (estimated)
- Lead sponsor
- Chi Dang HornikUniversity, hospital or other
- Collaborators
- The Emmes Company, LLC
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 9 Sep 2027 (estimated)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug of Interest | – | Drug: Ketorolac Tromethamine, Drug: Hydromorphone, Drug: Ketamine, Drug: Oxycodone, Drug: Morphine, Drug: Fentanyl (IV)Individuals receiving anesthetics or analgesics per standard of care |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (5 listed)
- 6 months to <18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range)
- Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)
- Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)
- Receiving one or more drugs of interest (DOI) per local standard of care
- Meeting DOI-specific inclusion criteria (See Appendices)
Key exclusion criteria (3 listed)
- Known pregnancy
- Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)
- Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineAlso: ToradolIV ketorolac will be given per standard of care, not prescribed for this study | Drug | Drug of Interest |
| HydromorphoneAlso: Hydromorphone hydrochloride, DilaudidIV Hydromorphone will be given per standard of care, not prescribed for this study | Drug | Drug of Interest |
| KetamineAlso: Ketamine HydrochlorideIV Ketamine will be given per standard of care, not prescribed for this study | Drug | Drug of Interest |
| OxycodoneAlso: Oxycodone HydrochloridePO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study | Drug | Drug of Interest |
| MorphineAlso: Morphine SulfateIV Morphine will be given per standard of care, not prescribed for this study | Drug | Drug of Interest |
| Fentanyl (IV)Also: Fentanyl CitrateFentanyl IV will be administered intravenously or intramuscularly per standard of care, not prescribed for this study | Drug | Drug of Interest |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Hornik, PharmD principal investigator
Duke Clinical Research Institute
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Pain, run by Chi Dang Hornik at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kady-Ann Steen-Burrell, PhD (919-530-9711, kady.ann.steen.burrell@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clearance (CL) or apparent oral clearance (CL/F) (time frame: up to 48 hours post dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.