TerminatedPhase 3

Intraoperative Methadone in Children Undergoing Surgery

Stopped: Slow recruitment due to covid-19 and organizational changes.

Denmark60 participantsStarted 2020-11-16

Plain-language summary

A prospective double-blind, randomized controlled trial investigating the effect of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in 96 children undergoing open urological surgery.

Who can participate

Age range

0 Years – 4 Years

Sex

MALE

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: Children scheduled for open urological surgery at the Outpatient Clinic at Aarhus University Hospital. Exclusion Criteria: * Age =/\> 5 years at the date of operation * Born preterm (Before gestational age of 37 weeks) * Congenital heart disease * Previous scrotal surgery * Laparoscopic operation * American Society of Anaesthesiologists (ASA) physical status lll, IV or V * Allergy to study drugs * Preoperative daily use of opioids * Parents with inability to provide informed consent * Severe respiratory insufficiency * Acute abdominal pain * Severe kidney insufficiency * Treatment with rifampicin

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

Patients consumption of analgesics in the PACU.

Timeframe: 3 hours

Pain intensity (highest score)

Timeframe: 3 hours

Trial details

NCT IDNCT04680286

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-30

View on ClinicalTrials.gov More Pain, Acute trials