ANZCTR - Registration

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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]

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

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Anaesthesiology

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]

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]

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]

60 minutes post randomisation

Secondary outcome [1]

Number of patients required rescue analgesia via documentation in the study tool kit and standard national drug chart.

Timepoint [1]

120 minutes post randomisation

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

16/07/2018

Actual

3/09/2018

Date of last participant enrolment

Anticipated

3/12/2018

Actual

25/11/2018

Date of last data collection

Anticipated

3/12/2018

Actual

25/11/2018

Sample size

Target

102

Accrual to date

Final

119

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Auckland City Hospital

Address [1]

2 Park Road, Grafton, Auckland
1023

Country [1]

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]

None

Name [1]

None

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability ethics committee

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

29/11/2017

Approval date [1]

02/02/2018

Ethics approval number [1]

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