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Trial registered on ANZCTR


Registration number
ACTRN12622001183774
Ethics application status
Approved
Date submitted
30/08/2022
Date registered
5/09/2022
Date last updated
5/09/2022
Date data sharing statement initially provided
5/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Restriction of Oxycodone in the Emergency Department (ROXY-ED): A Randomized Controlled Trial
Scientific title
Restriction of Oxycodone in the Emergency Department (ROXY-ED): A Randomized Controlled Trial
Secondary ID [1] 307870 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ROXY-ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 327489 0
Emergency medicine presentations with pain as a presenting complaint 327490 0
Condition category
Condition code
Emergency medicine 324611 324611 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Restriction of Oxycodone supply:
- An authorisation form will be required to be signed by an Emergency consultant immediately after Oxycodone is prescribed by a treating medical practitioner.
o The Emergency Physician will be required to document the indication.
- The medication will have to be dispensed by a clinical pharmacist.
o Nursing staff will not be able to access Oxycodone
- There will be no Oxycodone stored in the medication dispending system during the week randomised to the intervention arm.
Intervention code [1] 324337 0
Treatment: Drugs
Comparator / control treatment
Current standard practice.
Education regarding potential harm from opioid prescription and adherence to the analgesic ladder to medical and nursing staff will continue. There are no additional or focused education on analgesia as part of this trial. Standard education sessions at the recruiting institution are held weekly and delivered by senior clinicians.
The analgesic ladder is accessible from AlfredHealth's internal clinical guidelines and has been previously published. (ref: https://pubmed.ncbi.nlm.nih.gov/33735427/)

Nursing staff will be able to dispense Oxycodone whenever prescribed by a treating clinician.
Control group
Active

Outcomes
Primary outcome [1] 332429 0
Proportion of patients prescribed Oxycodone among those who “required analgesia”.
Patients who "required analgesia" will be identified through a review of medication dispensing logs and include all patients who were prescribed Paracetamol, Ibuprofen, Tramadol, Tapentadol, Morphine, Fentanyl or Oxycodone in the ED.
Timepoint [1] 332429 0
End of emergency care, i.e., discharge from the Emergency Department or admission to the ward
Secondary outcome [1] 413460 0
Pain scores on arrival and after analgesia.
These will be collected using an 11-point Likert scale (0-10).
Timepoint [1] 413460 0
On arrival: Pain scores will be documented at triage
After analgesia: pain scores will be documented 30 minutes after delivery of analgesia
Secondary outcome [2] 413461 0
Frequency of other analgesics other than Oxycodone.
This data will be retrospectively extracted from medical dispensing logs.
Timepoint [2] 413461 0
Discharge from the Emergency Department

Eligibility
Key inclusion criteria
All patients requiring analgesia in the Emergency Department
o “Requirement’ will be defined retrospectively by prescription of Paracetamol, Ibuprofen, Tramadol, Tapentadol, Morphine, Fentanyl or Oxycodone in the ED
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prehospital opioid administration
Oxycodone considered essential for patient.

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)
Sealed opaque enveloped prepared by Clinical Trial department.
To be opened at 0800hrs by pharmacist and trial co-ordinator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Randomisation will be by weeks.
On Monday morning at 0800h, the week will be randomised to an intervention (no Oxycodone) or control (Oxycodone). This allocation will continue will 0759h on the following Monday when a new randomisation envelope will be opened.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An intention to treat analysis will be undertaken. Two group comparisons will be done with the chi-square test, unless the number of acute adverse events was less than five, in which case, Fisher’s exact test will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/05/2022
Date of last participant enrolment
Anticipated
Actual
3/07/2022
Date of last data collection
Anticipated
Actual
3/07/2022
Sample size
Target
3500
Accrual to date
Final
3872
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23049 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 38379 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312145 0
Self funded/Unfunded
Name [1] 312145 0
Unfunded
Country [1] 312145 0
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
55 Commercial Rd.
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 313673 0
None
Name [1] 313673 0
None
Address [1] 313673 0
None
Country [1] 313673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311538 0
The Alfred Human Research and Ethics Committee
Ethics committee address [1] 311538 0
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 311538 0
Australia
Date submitted for ethics approval [1] 311538 0
25/03/2021
Approval date [1] 311538 0
13/05/2021
Ethics approval number [1] 311538 0
45/21

Summary
Brief summary
The widespread misuse of prescription opioids is a current ‘crisis’ that is already being faced in many countries, including the United States and Canada. Australia is rapidly following the same path as opioids are often prescribed to patients who present to EDs with pain. Australia now ranks eighth internationally on the number of daily doses of prescription opioids per million population (at approximately 40% the level of USA. A proportion of these would result from the prescribing of opioids by physicians in the emergency setting.

The principle hypothesis of this study is that restricted prescription of Oxycodone in the Emergency Department will significantly reduce
opioid prescription rates compared to current practice including educational programs
Trial website
Trial related presentations / publications
Public notes
List of investigators:
Biswadev Mitra
Timothy Amos
Holly Bannon-Murphy
Michael Dooley
Cristina Roman
Bertha Wu
Diana Goubrial
Ronald Huynh
De Villiers Smit
Peter A. Cameron

Contacts
Principal investigator
Name 121458 0
Prof Biswadev Mitra
Address 121458 0
Biswadev Mitra
Emergency & Trauma Centre
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 121458 0
Australia
Phone 121458 0
+61 3 9076 2782
Fax 121458 0
+61 3 9076 2699
Email 121458 0
[email protected]
Contact person for public queries
Name 121459 0
Biswadev Mitra
Address 121459 0
Biswadev Mitra
Emergency & Trauma Centre
The Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 121459 0
Australia
Phone 121459 0
+61 3 9076 2782
Fax 121459 0
+61 3 9076 2699
Email 121459 0
[email protected]
Contact person for scientific queries
Name 121460 0
Biswadev Mitra
Address 121460 0
Biswadev Mitra
Emergency & Trauma Centre
The Alfred Hospital55 Commercial Rd
Melbourne VIC 3004
Country 121460 0
Australia
Phone 121460 0
+61 3 9076 2782
Fax 121460 0
+61 3 9076 2699
Email 121460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is conducted under ethics approval with waiver for the requirement to seek informed consent. Participants did not provide their consent for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17064Study protocol  [email protected]
17065Ethical approval  [email protected] 384600-(Uploaded-30-08-2022-12-42-35)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRestriction of oxycodone in the emergency department (ROXY-ED): A randomised controlled trial.2023https://dx.doi.org/10.1177/20494637231189031
N.B. These documents automatically identified may not have been verified by the study sponsor.