A Phase 4 interventional study of Morphine and Oxycodone in Patient-Controlled Analgesia, sponsored by Murdoch Childrens Research Institute. Recruiting at 1 site in Australia. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Murdoch Childrens Research Institute · Phase 4, Interventional, and Treatment
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:
Study activities are as follows:
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).
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 690 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Murdoch Childrens Research Institute is the lead sponsor of 96 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Intravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout
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
Antiemetic use
Prescription incidence and administration of any of the following to participant: Granisetron, Ondansetron, Droperidol, Metoclopramide, Cyclizine, Dexamethasone, and Promethazine
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
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.
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
Indicated by need for an in-dwelling catheter (IDC) insertion
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Plan to share: 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).
Supporting information: Study protocol, Sap, Icf, Analytic code
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