About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Morphine
DrugIntravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout
Oxycodone
DrugIntravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout
Treatment groups
Trial outcomes
Primary outcomes
Antiemetic use
Prescription incidence and administration of any of the following to participant: Granisetron, Ondansetron, Droperidol, Metoclopramide, Cyclizine, Dexamethasone, and Promethazine
Secondary outcomes
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.
Incidence of Urinary Retention
Indicated by need for an in-dwelling catheter (IDC) insertion
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
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)
Sponsors and contacts
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