The Royal Children's Hospital
Melbourne, Victoria, 3052, Australia
Location status: Recruiting
Location contact
Justine Adams
CONTACT
Su May Koh
CONTACT
NCT Number: NCT06186141
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
Interested in participating?
Request Info6 year–18 year
All sexes
Interventional
Phase 4
Melbourne, Victoria, 3052, Australia
Location status: Recruiting
Justine Adams
CONTACT
Su May Koh
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Oxycodone Juno, Oxycodone HCI Medsurge
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
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.
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: From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
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.
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.
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.
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.
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.
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.
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 will be measured using the documentation of number of vomiting episodes. This will be reported for each day over the study period.
Contact information is provided by the study sponsor or research team.
Justine Adams
CONTACT
Suzette Sheppard
CONTACT
Murdoch Childrens Research Institute
Other
A Comparison of Nausea and Vomiting in Postoperative Paediatric Patients With Patient-controlled Analgesia (PCA): Morphine vs Oxycodone (POPCORN)
Acronym: POPCORN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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