RecruitingPhase 4

Nausea and Vomiting in Postoperative Paediatric Patients With Patient-Controlled Analgesia (PCA): Morphine vs Oxycodone

Australia690 participantsStarted 2024-03-13

Plain-language summary

POPCORN trial will compare the side effects and effectiveness of Morphine versus Oxycodone medication when prescribed for use as patient controlled analgesia (PCA) for pain relief for paediatric patients after-surgery. This trial is embedded into routine patient care using the hospital electronic medical record (EMR). Participants will be randomly assigned to either medication after they enrol in the study. The main questions the POPCORN trial aims to answer are: * 1\. Is there a difference in the usage of medication to treat nausea and vomiting for those who received oxycodone PCA versus morphine PCA for post-surgery pain relief? * 2\. Is there a difference in side effects or pain relief needed between the two groups? Study activities are as follows: * Participants enrolled to study during their pre-operative consultation * Participants are randomly assigned to morphine or oxycodone * No further study-specific activities expected from participant after enrolment and randomisation * Participant receives routine medical care as planned * Clinicians record assessments as per routine care in electronic medical record (EMR) * EMR data are extracted as trial data

Who can participate

Age range

6 Years – 18 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: * Postoperative patients who are appropriate for a PCA including those aged 6 and above and up to age 18 years. * Those deemed appropriate for either morphine or oxycodone by their treating anaesthetist. * American Society of Anaesthesiologists (ASA) score 1-3 inclusive * Those whose parents or legal guardians have provided informed consent on the patient's behalf. Exclusion Criteria: * Any patients with an allergy, hypersensitivity, or contraindication to morphine or oxycodone. * Patients in the age group with significant intellectual disability or physical incapacity rendering them incapable of using the PCA device * ASA score 4 or above * Inability or unwillingness of parent or legal guardian to provide informed consent for the study.

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

Antiemetic use

Timeframe: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.

Trial details

NCT IDNCT06186141

SponsorMurdoch Childrens Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Justine Adams

03 8341 6200 justine.adams@mcri.edu.au

View on ClinicalTrials.gov More Patient-Controlled Analgesia trials