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Trial registered on ANZCTR


Registration number
ACTRN12618000020280
Ethics application status
Approved
Date submitted
29/11/2017
Date registered
11/01/2018
Date last updated
10/12/2018
Date data sharing statement initially provided
2/11/2018
Date results information initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Paracetamol versus combination analgesics for injury pain
Scientific title
Single dose paracetamol alone versus Paracetamol plus other oral analgesics for moderate and severe pain from limb and trunk injuries in the Emergency Department: A Randomised Controlled Trial
Secondary ID [1] 293206 0
Nil known
Universal Trial Number (UTN)
U1111-1205-3744
Trial acronym
Paracetamol Analgesics in Emergency Department: PAinED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 305234 0
Condition category
Condition code
Injuries and Accidents 304540 304540 0 0
Other injuries and accidents
Anaesthesiology 305005 305005 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study arm:
Paracetamol 500mgx2 oral tablets once
Ibuprofen 200mgx2 oral tablets once
codeine 60mgx1 oral capsule once
All are administered at the same time and only once.
Intervention code [1] 299476 0
Treatment: Drugs
Comparator / control treatment
Active control arm:
Paracetamol 500mgx2 oral tablets once
Placebo capsules x3 once: Gelatin capsules with lactose filling.
All are administered at the same time and only once.
Control group
Active

Outcomes
Primary outcome [1] 303776 0
Difference in mean pain score based on a standard 11 point verbal rating scale (VRS) between groups, The 11 point VRS is a standard tool to assess level of pain that is used in our Emergency Department.
A 1.3 difference been nominated as clinically detectable.
Timepoint [1] 303776 0
60 minutes post randomisation
Secondary outcome [1] 340117 0
Number of patients required rescue analgesia via documentation in the study tool kit and standard national drug chart.
Timepoint [1] 340117 0
120 minutes post randomisation
Secondary outcome [2] 340440 0
Adverse effects will be limited to a questionnaire of yes/no, if patient does say 'yes' then the full details of the adverse reaction including:
* What Adverse effect was experienced
* Brief description of the adverse effect
* Severity
* Action taken
Timepoint [2] 340440 0
60 minutes and 120 minutes

Eligibility
Key inclusion criteria
• Age: 18-65
• Moderate to severe pain (3/10 or higher on a Verbal Rating Scale 0-10 on admission)
• Acute closed limb or trunk injury (previous 48 hour)
• Oral analgesia deemed suitable
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Need for time critical interventions (e.g. reduction of dislocations)
• Digital injuries (treated with nerve blocks)
• Pregnant or breastfeeding women
• NSAID sensitive asthma
• Active peptic ulcer disease
• Known renal function impairment
• Known liver function impairment
• Acute intoxication (any substance)
• Already received analgesia within four hours prior to admission
• Regular use of analgesic agents for chronic pain
• Allergies or prior adverse reaction to any of the study medications
• Inability to take oral medication
• Inability to understand the study explanation (any reason)
• Unwillingness to comply with recommendations to not drive, consume alcohol or operate machinery for at least 6 hours after being given the study medication
• Open injuries
• Patient with multi-trauma
• Patient with head injuries

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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9320 0
New Zealand
State/province [1] 9320 0
Auckland

Funding & Sponsors
Funding source category [1] 297837 0
Hospital
Name [1] 297837 0
Auckland City Hospital
Address [1] 297837 0
2 Park Road, Grafton, Auckland
1023
Country [1] 297837 0
New Zealand
Primary sponsor type
Individual
Name
Associate Professor Peter Jones
Address
Adult Emergency Department
Auckland City hospital, level 2
2 Park Road, Grafton.
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 296888 0
None
Name [1] 296888 0
None
Address [1] 296888 0
N/A
Country [1] 296888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298884 0
Health and Disability ethics committee
Ethics committee address [1] 298884 0
Ethics committee country [1] 298884 0
New Zealand
Date submitted for ethics approval [1] 298884 0
29/11/2017
Approval date [1] 298884 0
02/02/2018
Ethics approval number [1] 298884 0
17/CEN/270

Summary
Brief summary
The aim of our study is to compare the efficacy of a single dose paracetamol to a combination of pain relief with paracetamol, ibuprofen and codeine. Our hypothesis is that the combination will be significantly better than the single agent. This will then provide better guidance to clinicians on the use of pain relief in acute minor injuries that are presented to the Emergency Department, and to avoid over-prescribing of opioids. There are very good data internationally to show that the beginning of opioid addiction starts in the acute setting (Barnett 2017). We also know from many other studies that the combination of anti-inflammatories and paracetamol do not provide significantly more benefit compared to paracetamol alone (Man 2004, Woo 2005, Bondarsky 2013, Ridderikhof 2017). Other studies have also demonstrated that the combination of paracetamol and opioids to paracetamol and anti-inflammatories does not provide significant benefit (Graudins 2016, Chang 2017). There have also been a meta-analysis performed to compare anti-inflammatory only to a combination of pain relief which also showed similar efficacy (Jones 2015). Thus we will attempt to address the gap in our current literature of pain management by comparing paracetamol alone to a combination of all three agents.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2170 2170 0 0
/AnzctrAttachments/373874-Bondarsky 2013.pdf (Publication)
Attachments [2] 2171 2171 0 0
/AnzctrAttachments/373874-Man 2004.pdf (Publication)
Attachments [3] 2172 2172 0 0
/AnzctrAttachments/373874-Woo2005.pdf (Publication)
Attachments [4] 2173 2173 0 0
Attachments [6] 2184 2184 0 0
Attachments [7] 2185 2185 0 0
Attachments [8] 2186 2186 0 0
/AnzctrAttachments/373874-Participant Information Sheet_V3.docx (Participant information/consent)
Attachments [9] 2187 2187 0 0
/AnzctrAttachments/373874-Informed Consent Form_InjuryAnalgesia_V3.docx (Participant information/consent)
Attachments [10] 2188 2188 0 0
Attachments [11] 2260 2260 0 0

Contacts
Principal investigator
Name 78554 0
Mr Jiayi Gong
Address 78554 0
Auckland City Hospital
2 Park Road Grafton
Inpatient Pharmacy, level 6, Support Building
Auckland
1023
Country 78554 0
New Zealand
Phone 78554 0
+64274124716
Fax 78554 0
Email 78554 0
Jayg@adhb.govt.nz
Contact person for public queries
Name 78555 0
Mr Jiayi Gong
Address 78555 0
Auckland City Hospital
2 Park Road Grafton
Inpatient Pharmacy, level 6, Support Building
Auckland
1023
Country 78555 0
New Zealand
Phone 78555 0
+64274124716
Fax 78555 0
Email 78555 0
Jayg@adhb.govt.nz
Contact person for scientific queries
Name 78556 0
A/Prof Peter Jones
Address 78556 0
Auckland City Hospital
2 Park Road Grafton
Adult's Emergency Department, Level 2, Main building
Auckland
1023
Country 78556 0
New Zealand
Phone 78556 0
+6421537646
Fax 78556 0
Email 78556 0
PeterJ@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
To be discussed post completion of enrollment
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary