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Trial registered on ANZCTR


Registration number
ACTRN12616000941460
Ethics application status
Approved
Date submitted
12/07/2016
Date registered
15/07/2016
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Date results provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of mild opioids versus strong opioids for post-discharge analgesia following orthopaedic fracture surgery
Scientific title
A randomised control trial of oxycodone hydrochloride versus paracetamol with codeine for post-discharge analgesia following orthopaedic fracture surgery
Secondary ID [1] 289356 0
None
Universal Trial Number (UTN)
U1111-1183-7247
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 298986 0
Fracture 298987 0
Orthopaedic Surgery 298988 0
Condition category
Condition code
Injuries and Accidents 299051 299051 0 0
Fractures
Anaesthesiology 299444 299444 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paracetamol 500mg and Codeine phosphate 8mg
1-2 oral tablets, 4 times per day for 2 weeks (Maximum allowed 8 tablets in 24hrs) followed by dose reduction to cessation during week 3.
Total number of tablets taken (1 or 2) will be determined by patient during days 1 -14.
Adherence will be monitored via patient self-report during trial period then tablet return on study completion.
Intervention code [1] 294940 0
Treatment: Drugs
Comparator / control treatment
Oxycodone Hydrochloride 5mg
1-2 oral tablets, 4 times per day for 2 weeks (Maximum allowed 8 tablets in 24hrs) followed by dose reduction to cessation during week 3.
Total number of tablets taken (1 or 2) will be determined by patient pain during days 1 -14..
Adherence will be monitored via patient self-report during trial period then tablet return on study completion.
Control group
Active

Outcomes
Primary outcome [1] 298521 0
Pain (Numeric Pain Rating Scale (NRS-11))
Timepoint [1] 298521 0
Average of first 7 days of treatment. (Day 1, 2, 3, 4, 5, 6 & 7)
Secondary outcome [1] 324452 0
Quality of life (EQ-5D-5L)
Timepoint [1] 324452 0
Baseline, Day 3, 7, 14 & 21
Secondary outcome [2] 325482 0
Mobility (Question 1 of EQ-5D-5L)
Timepoint [2] 325482 0
Baseline, Days 3, 7, 14, 21
Secondary outcome [3] 325483 0
Pain (The Numeric Pain Rating scale)
Timepoint [3] 325483 0
Collected Daily, average of Days 8-21 of treatment
Secondary outcome [4] 325484 0
Treatment Adverse events
(Self report, Yes or No to common known adverse reactions) (Constipation, Drowsiness, Nausea, Vomiting, Hallucinations, Dizziness, Confusion and Skin rash)
Timepoint [4] 325484 0
Collected daily, Days 1-21
Secondary outcome [5] 325485 0
Global perceived effect (Likert scale; -5 (vastly worse) to 0 (unchanged), to +5 (completely recovered)..
Timepoint [5] 325485 0
Days 3, 7, 14 & 21
Secondary outcome [6] 325588 0
Return to work (Yes or No, subject self-report)
Timepoint [6] 325588 0
Day 21

Eligibility
Key inclusion criteria
Orthopaedic fracture of a long bone (humerus, radius, ulna, femur, tibia or fibula) or the pelvis, patella, calcaneus or talus requiring surgical fixation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pathological fractures
- Multi-system trauma injuries (major head, chest or abdominal injuries)
- Major infection following surgery
- Opioid dependency

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
27/07/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
28/10/2017
Date of last data collection
Anticipated
21/08/2017
Actual
18/11/2017
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5899 0
Liverpool Hospital - Liverpool

Funding & Sponsors
Funding source category [1] 293739 0
Government body
Name [1] 293739 0
State Insurance Regulatory Authority
Country [1] 293739 0
Australia
Primary sponsor type
Individual
Name
Professor Ian Harris
Address
Liverpool Hospital
Orthopaedic Department
Locked Bag 7103
Liverpool BC NSW 1871
Country
Australia
Secondary sponsor category [1] 292833 0
None
Name [1] 292833 0
Address [1] 292833 0
Country [1] 292833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295173 0
Hunter new england human research ethics committee
Ethics committee address [1] 295173 0
Ethics committee country [1] 295173 0
Australia
Date submitted for ethics approval [1] 295173 0
30/04/2015
Approval date [1] 295173 0
16/07/2015
Ethics approval number [1] 295173 0
HREC/15/HNE/158

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

Contacts
Principal investigator
Name 65470 0
Prof Ian Harris
Address 65470 0
Orthopaedic Department
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 65470 0
Australia
Phone 65470 0
+61 2 8738 9254
Fax 65470 0
Email 65470 0
iaharris1@gmail.com
Contact person for public queries
Name 65471 0
Deanne Jenkin
Address 65471 0
Ingham Institute of Applied Medical Research
1 Campbell street
Liverpool NSW 2170
Country 65471 0
Australia
Phone 65471 0
+61 2 8738 9254
Fax 65471 0
Email 65471 0
deanne.jenkin@sswahs.nsw.gov.au
Contact person for scientific queries
Name 65472 0
Deanne Jenkin
Address 65472 0
Ingham Institute of Applied Medical Research
1 Campbell street
Liverpool NSW 2170
Country 65472 0
Australia
Phone 65472 0
+61 2 8738 9254
Fax 65472 0
Email 65472 0
deanne.jenkin@sswahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Consideration on case by case basis


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of Oxycodone Hydrochloride (Strong Opioid) vs Combination Acetaminophen and Codeine (Mild Opioid) for Subacute Pain after Fractures Managed Surgically: A Randomized Clinical Trial.2021https://dx.doi.org/10.1001/jamanetworkopen.2021.34988
N.B. These documents automatically identified may not have been verified by the study sponsor.