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

NCT06186141 | Recruiting Phase 4

• 1 other identifier: 91523
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Patient-Controlled Analgesia

Keywords

Post-operative Pain; Paediatric; Patient-controlled analgesia; Paediatric analgesia; Post-operative; Embedded clinical trials

Outcome Measures

Primary Outcomes (1)

• Antiemetic use

  Prescription incidence and administration of any of the following to participant: Granisetron, Ondansetron, Droperidol, Metoclopramide, Cyclizine, Dexamethasone, and Promethazine

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

Secondary Outcomes (9)

• Incidence of Respiratory Depression

  The time at which the PCA is first attached to the child and either up to 72 hours or 4 hours after ceasing PCA, whichever is first.

• Incidence of Urinary Retention

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

• Reports of Itch

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

• Reports of Nausea

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

• Sedation levels

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

Study Arms (2)

Intravenous (IV) Morphine Patient controlled analgesia (PCA)

ACTIVE COMPARATOR

Morphine PCA IV 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout- as per current RCH Children's Pain Management Service (CPMS) dosing and use.

Drug: Morphine

IV Oxycodone PCA

ACTIVE COMPARATOR

Oxycodone PCA IV 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout- as per current RCH Children's Pain Management Service (CPMS) dosing and use.

Drug: Oxycodone

Interventions

Morphine DRUG

Intravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout

Intravenous (IV) Morphine Patient controlled analgesia (PCA)

Oxycodone DRUG

Intravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout

Also known as: Oxycodone Juno, Oxycodone HCI Medsurge

IV Oxycodone PCA

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

The Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine

Study Officials

• Sue May Koh

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justine Adams

CONTACT

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

Suzette Sheppard

CONTACT

03 9345 4901; Suzette.sheppard@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study will not be blinded due to the need for opioid syringes to be readily identifiable on the ward.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single site randomised embedded trial comparing the side effects of two standard intravenous opioid PCAs, namely morphine and oxycodone. There are two treatment arms, namely morphine and oxycodone, with patients randomised to each arm. Apart from the consent and randomisation process there will be no change to current pre-existing practices for PCAs and patient care.

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: December 29, 2023
• Study Start: March 13, 2024
• Primary Completion: March 19, 2026
• Study Completion (Estimated): March 19, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 12 months following analysis and publication of the primary outcome
• Access Criteria: Requests for access to previously published anonymised datasets by the scientific community will be reviewed and determined by an independent committee within the MCRI and in accordance with institute policy.

Locations

AU (1)