Patient-Controlled AnalgesiaPhase 4POPCORNNCT06186141
Nausea and Vomiting in Postoperative Paediatric Patients With Patient-Controlled Analgesia (PCA): Morphine vs Oxycodone
A Phase 4 study testing Morphine and Oxycodone in people with Patient-Controlled Analgesia, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Patient-Controlled Analgesia
- What is being tested?
- Morphine and Oxycodone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Mar 2024to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The Royal Children's Hospital
Melbourne, Victoria, 3052
Justine Adams, 03 8341 6200, justine.adams@mcri.edu.au
Su May Koh, 03 9345 5233, Su.Koh@rch.org.au
About this study
Official title: A Comparison of Nausea and Vomiting in Postoperative Paediatric Patients With Patient-controlled Analgesia (PCA): Morphine vs Oxycodone (POPCORN)
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:
Read more
- 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
Read the detailed description
Morphine and oxycodone are commonly used intravenous (IV) opioids in adult and paediatric post-operative patients. Traditionally, morphine has been preferentially prescribed with PCA. However, IV oxycodone is rapidly becoming more popular. Despite systematic reviews describing their use within the adult population, very little is known about the comparative side-effect profiles of morphine versus oxycodone within the paediatric post-operative population. Both options are currently in use and considered standard of care at The Royal Children's Hospital (RCH), Melbourne, Australia. However, there is limited literature to support a clinician's choice between IV oxycodone PCA versus IV morphine PCA.
The aim of this embedded randomized controlled trial is to compare the side-effect profile of IV oxycodone PCA to IV morphine PCA in post-operative paediatric patients.
This is a single site, randomised, embedded trial with two intervention arms, namely IV morphine PCA and IV oxycodone PCA. The study will not be blinded due to the need for opioid syringes to be readily identifiable on the ward. Apart from the consent and randomisation process, there will be no change to current pre-existing practices around PCA use and patient care. Adopting a health informatics approach; patient identification, consent, randomization and reporting of outcomes will be embedded within the EMR.
The primary objective is to compare antiemetic use between the two intervention arms. The secondary objectives will be a comparison of PCA side effects, efficacy and opioid use between the two arms. Outcome data must be what is already recorded as part of usual clinical care within the EMR including: antiemetic administration, respiratory depression (new oxygen and/or high dose naloxone use), urinary retention (need for in-dwelling catheter insertion), constipation (medication laxative administration), itch (RCH Itch Score (0-4 Likert scale)), nausea and vomiting, sedation (0-4 University of Michigan Scoring System), pain (Wong-Baker FACES Pain Rating Scale/Visual Analogue Scale (VAS 0-10) and total opioid consumption (mg/kg/day).
- Conditions
- Patient-Controlled Analgesia
- Being tested
- Morphine, Oxycodone
- Keywords
- Post-operative Pain, Paediatric, Patient-controlled analgesia, Paediatric analgesia, Post-operative, Embedded clinical trials
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Intravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout
OxycodoneDrug
Also called Oxycodone Juno, Oxycodone HCI Medsurge
Intravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antiemetic use
Prescription incidence and administration of any of the following to participant: Granisetron, Ondansetron, Droperidol, Metoclopramide, Cyclizine, Dexamethasone, and Promethazine
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcomes (9)
Incidence of Respiratory Depression
Measured as any new oxygen and/or high dose naloxone use (10mcg/kg to max of 400mcg). This will exclude administration of low dose naloxone when used to manage incidence of itch.
Measured: 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
Indicated by need for an in-dwelling catheter (IDC) insertion
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Reports of Itch
Measured using RCH Itch Score (0-4 Likert scale) where a higher score indicates worse pruritus/itch.
0=comfortable, no itch, 1=itches a little, doesn't interfere with activity, 2= itches more, sometimes interferes with activity, 3= itches a lot, difficult to be still/concentrate, 4= itches most terribly, impossible to sit still/concentrate
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Reports of Nausea
Measured via 0-10 visual analogue scale (VAS) scale Nausea will be measured using the nausea scale (0-10 Baxter Retching Faces scale / VAS)
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Sedation levels
Measured via University of Michigan Scoring System (0-4 scale) where a higher score indicates higher sedation level.
0= awake and alert, 1= minimally sedated, 2=moderately sedated, 3=deep sedation, 4=unrousable
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Incidence of Constipation
Recorded laxative administered is indicative. Medication laxatives only, no food laxatives.
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Reported pain levels
Measured via Wong-Baker FACES Pain Rating Scale or Visual Analogue Scale (0-10) higher is more pain. If both a pain scale and a rating are reported but don't align the higher of the two will be used.
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Total opioid consumption
All opioids administered, including any background infusions are accurately documented in the EMR. Total opioid administered will be calculated from the EMR. The total morphine equivalent dose will be calculated.
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Incidence of Vomiting
Incidence of vomiting will be measured using the documentation of number of vomiting episodes. This will be reported for each day over the study period.
Measured: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start13 Mar 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient-Controlled AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sue May Koh, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186141
- Sponsor's protocol ID
- 91523
- Acronym
- POPCORN
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Beginning 12 months following analysis and article publication, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by the Murdoch Children's Research Institute's (MCRI's) independent data use review committee (not including trial sponsor-investigator) and who accept MCRI's conditions, under a collaborator agreement, for accessing participant data after de-identification (text, tables, figures, and appendices) that underlies reported results, along with trial protocol, Statistical Analysis Plan (SAP) and Participant Information and Consent Forms (PICF).
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Nausea and Vomiting in Postoperative Paediatric Patients With Patient-controlled Analgesia (PCA): Morphine vs Oxycodone (POPCORN)
- ClinicalTrials.gov ID
- NCT06186141
- Acronym / sponsor ID
- POPCORN / 91523
- Conditions
- Patient-Controlled Analgesia
- Keywords
- Post-operative Pain, Paediatric, Patient-controlled analgesia, Paediatric analgesia, Post-operative, Embedded clinical trials
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Morphine and oxycodone are commonly used intravenous (IV) opioids in adult and paediatric post-operative patients. Traditionally, morphine has been preferentially prescribed with PCA. However, IV oxycodone is rapidly becoming more popular. Despite systematic reviews describing their use within the adult population, very little is known about the comparative side-effect profiles of morphine versus oxycodone within the paediatric post-operative population. Both options are currently in use and considered standard of care at The Royal Children's Hospital (RCH), Melbourne, Australia. However, there is limited literature to support a clinician's choice between IV oxycodone PCA versus IV morphine PCA.
The aim of this embedded randomized controlled trial is to compare the side-effect profile of IV oxycodone PCA to IV morphine PCA in post-operative paediatric patients.
This is a single site, randomised, embedded trial with two intervention arms, namely IV morphine PCA and IV oxycodone PCA. The study will not be blinded due to the need for opioid syringes to be readily identifiable on the ward. Apart from the consent and randomisation process, there will be no change to current pre-existing practices around PCA use and patient care. Adopting a health informatics approach; patient identification, consent, randomization and reporting of outcomes will be embedded within the EMR.
The primary objective is to compare antiemetic use between the two intervention arms. The secondary objectives will be a comparison of PCA side effects, efficacy and opioid use between the two arms. Outcome data must be what is already recorded as part of usual clinical care within the EMR including: antiemetic administration, respiratory depression (new oxygen and/or high dose naloxone use), urinary retention (need for in-dwelling catheter insertion), constipation (medication laxative administration), itch (RCH Itch Score (0-4 Likert scale)), nausea and vomiting, sedation (0-4 University of Michigan Scoring System), pain (Wong-Baker FACES Pain Rating Scale/Visual Analogue Scale (VAS 0-10) and total opioid consumption (mg/kg/day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) Morphine Patient controlled analgesia (PCA) | Active comparator | Drug: MorphineMorphine 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. |
| IV Oxycodone PCA | Active comparator | Drug: OxycodoneOxycodone 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineIntravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout | Drug | Intravenous (IV) Morphine Patient controlled analgesia (PCA) |
| OxycodoneAlso: Oxycodone Juno, Oxycodone HCI MedsurgeIntravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout | Drug | IV Oxycodone PCA |
Primary outcome
Antiemetic use
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Prescription incidence and administration of any of the following to participant: Granisetron, Ondansetron, Droperidol, Metoclopramide, Cyclizine, Dexamethasone, and Promethazine
9 secondary outcomes
Incidence of Respiratory Depression
Time frame: 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
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Reports of Itch
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Reports of Nausea
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Sedation levels
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Incidence of Constipation
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Reported pain levels
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Total opioid consumption
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Incidence of Vomiting
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. Beginning 12 months following analysis and article publication, the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by the Murdoch Children's Research Institute's (MCRI's) independent data use review committee (not including trial sponsor-investigator) and who accept MCRI's conditions, under a collaborator agreement, for accessing participant data after de-identification (text, tables, figures, and appendices) that underlies reported results, along with trial protocol, Statistical Analysis Plan (SAP) and Participant Information and Consent Forms (PICF).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue May Koh principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine and Oxycodone in people with Patient-Controlled Analgesia, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justine Adams (03 8341 6200, justine.adams@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antiemetic use (time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.