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Kids' drug dosing mystery: new study aims to crack the code

NCT ID NCT03427736

Knowledge-focused Sponsor: Chi Dang Hornik Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This study tracks how common pain and anesthesia drugs behave in the bodies of children and teens aged 0 to 18. Researchers will measure drug levels in up to 500 participants who are already receiving these medications as part of their standard care. The goal is to create better dosing guidelines tailored to young patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ketorolac, Hydromorphone, Ketamine, Oxycodone, Morphine
What this could lead to
If successful, this could lead to safer, more effective dosing guidelines for pain and anesthesia drugs in children.
What could go wrong
This is an observational study, not a treatment trial. It only measures drug levels, so it won't directly improve care for participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 551 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2018

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

0 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 0 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) 2. Parent and/or participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable) 3. Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB) 4. Receiving one or more drugs of interest (DOI) per local standard of care 5. Meeting DOI-specific inclusion criteria (See Appendices) Exclusion Criteria: 1. Known pregnancy 2. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device) 3. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia Pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 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

  • Baylor College of Medicine

    WITHDRAWN

    Houston, Texas, 77030, United States

  • Cardinal Glennon Children's Hospital

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63104, United States

  • Children's Hospital Colorado

    TERMINATED

    Aurora, Colorado, 80045, United States

  • Dell Children's Medical Center of Texas

    WITHDRAWN

    Austin, Texas, 78723, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27701, United States

  • Hospital Sainte-Justine

    ACTIVE_NOT_RECRUITING

    Montreal, Quebec, T3T 1C5, Canada

  • Lucile Packard Children's Hospital

    RECRUITING

    Stanford, California, 94305, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Oregon Health and Science University

    ACTIVE_NOT_RECRUITING

    Portland, Oregon, 97239, United States

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Washington University School of Medicine

    ACTIVE_NOT_RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.