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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06186141




Registration number
NCT06186141
Ethics application status
Date submitted
16/12/2023
Date registered
29/12/2023

Titles & IDs
Public title
Nausea and Vomiting in Postoperative Paediatric Patients With Patient-Controlled Analgesia (PCA): Morphine vs Oxycodone
Scientific title
A Comparison of Nausea and Vomiting in Postoperative Paediatric Patients With Patient-controlled Analgesia (PCA): Morphine vs Oxycodone (POPCORN)
Secondary ID [1] 0 0
91523
Universal Trial Number (UTN)
Trial acronym
POPCORN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient-Controlled Analgesia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Morphine
Treatment: Drugs - Oxycodone

Active comparator: Intravenous (IV) Morphine Patient controlled analgesia (PCA) - 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.

Active comparator: IV Oxycodone PCA - 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.


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

Treatment: Drugs: Oxycodone
Intravenous (IV) delivery via Patient Controlled Analgesia device (PCA) 20mcg/kg bolus to a maximum of 1mg with a 5-minute lockout
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Antiemetic use
Timepoint [1] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [1] 0 0
Incidence of Respiratory Depression
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Incidence of Urinary Retention
Timepoint [2] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [3] 0 0
Reports of Itch
Timepoint [3] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [4] 0 0
Reports of Nausea
Timepoint [4] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [5] 0 0
Sedation levels
Timepoint [5] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [6] 0 0
Incidence of Constipation
Timepoint [6] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [7] 0 0
Reported pain levels
Timepoint [7] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [8] 0 0
Total opioid consumption
Timepoint [8] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.
Secondary outcome [9] 0 0
Incidence of Vomiting
Timepoint [9] 0 0
From PCA attachment to 72 hours or 4 hours after ceasing PCA, whichever is first.

Eligibility
Key inclusion criteria
* 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.
Minimum age
6 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/03/2027
Actual
Sample size
Target
690
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sue May Koh
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Justine Adams
Address 0 0
Country 0 0
Phone 0 0
03 8341 6200
Fax 0 0
Email 0 0
justine.adams@mcri.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
12 months following analysis and publication of the primary outcome
Available to whom?
Requests for access to previously published anonymised datasets by the scientific community will be reviewed and determined by an independent committee within the MCRI and in accordance with institute policy.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06186141