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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-18
SponsorMurdoch Childrens Research Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Morphine

    Drug

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

  • Oxycodone

    Drug

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

Treatment groups

690 Participants
are divided into 2 treatment groups
Group A: Intravenous (IV) Morphine Patient controlled analgesia (PCA)Active comparator 1 intervention
Group B: IV Oxycodone PCAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

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