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Kids' painkiller mystery: anesthesia may change how oxycodone works

NCT ID NCT03054831

Knowledge-focused Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how general anesthesia changes the way children process liquid oxycodone, a common painkiller used after surgery. Researchers will give the drug to 40 children aged 2-8 at different times during anesthesia and measure its levels in the blood. They will also check if certain genes affect how the drug is broken down. The goal is to understand how to dose oxycodone more safely in kids.

What this could mean

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

Active substance
liquid oxycodone
What this could lead to
If successful, this could help doctors give safer, more effective pain relief to children during and after surgery.
What could go wrong
This is a small, early-phase study with only 40 children. It focuses on drug levels, not on proving pain relief or safety. Results may not apply to all kids.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

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

Started

Jul 2019

Expected to finish

Dec 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.

Ages

2 to 8 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: All patients are scheduled for the following in-patient surgical procedures: * hypospadias repair * ureteral reimplantation * pyeloplasty (Genitourinary Surgery Service) and age between 2-8 years, and opioid naive, and not meet exclusion criteria Exclusion Criteria: * currently taking cytochrome P450(CYP) 3A4 or 2D6 inhibitors/inducers * known history of allergy to oxycodone * known gastrointestinal, hepatic, or renal dysfunction * known sleep apnea or impaired respiratory reserve * speak a language other than English

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As listed by the trial registrant

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

Liquid oxycodone

Contacts and locations

Locations

  • Boston Children Hospital

    Boston, Massachusetts, 02115, United States