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

• Status: Recruiting
• Trial end date: 2027-03-19
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Treatments: Morphine; Oxycodone

Criteria

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.