Active — Not RecruitingPhase 4

The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric

United States40 participantsStarted 2019-07-08

Plain-language summary

Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. The investigators would like to find out more about how general anesthesia (GA) effects how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, the investigators would like to give oxycodone to surgical patients (group one will receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of GA) at Boston Children's Hospital then measure its metabolic activity and also perform a specific genetic analysis.

Who can participate

Age range

2 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the effect of general anesthesia on plasma oxycodone level in patients age 2-5 years .

Timeframe: upto 24 weeks

the effect of general anesthesia on plasma oxycodone level in patients age 6-8 years

Timeframe: up to 24 weeks

Trial details

NCT IDNCT03054831

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Liquid Oxycodone trials