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Trial registered on ANZCTR


Registration number
ACTRN12615000481572
Ethics application status
Approved
Date submitted
9/04/2015
Date registered
15/05/2015
Date last updated
18/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, double-blind, double-dummy, randomised controlled trial to compare pain relief from intravenous paracetamol and oral paracetamol in acute pain patients presenting to the Emergency Department
Scientific title
A prospective, double-blind, double-dummy, randomised controlled trial to compare pain relief from intravenous paracetamol and oral paracetamol in acute pain patients presenting to the Emergency Department
Secondary ID [1] 286499 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 294709 0
Condition category
Condition code
Injuries and Accidents 295000 295000 0 0
Other injuries and accidents
Anaesthesiology 295130 295130 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: paracetamol 1 gram, intravenous as a single dose
Arm 2: paracetamol 1 gram, oral as a single dose


Intervention code [1] 291592 0
Treatment: Drugs
Comparator / control treatment
Arm 1: Placebo of oral preparation as a single dose
Arm 2: Normal saline 100mls Intravenous as a single dose
Control group
Active

Outcomes
Primary outcome [1] 294751 0
Pain Scores: Visual Analogue Scale
Timepoint [1] 294751 0
Time of intervention and then at 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes from intervention administration.
Secondary outcome [1] 313989 0
Patient Satisfaction as assessed on a 5 point Likert scale
Timepoint [1] 313989 0
At the conclusion of the trial; 4 hours.
Secondary outcome [2] 313990 0
Adverse Effects such as skin reaction, irritation at injection site, hypotension or other.
Timepoint [2] 313990 0
Any point throughout the trial from the time of intervention to 4 hours post.
Secondary outcome [3] 313991 0
Length of Emergency Department stay
Timepoint [3] 313991 0
Patient discharge or transfer from the Emergency Department
Secondary outcome [4] 313993 0
Need for rescue analgesia
Timepoint [4] 313993 0
Any timepoint throughout the trial from the time of intervention to 4 hours post.

Eligibility
Key inclusion criteria
Age greater than or equal to 18years

Already has intravenous access or has a clinical condition indicating that intravenous access is required

Have received at least one initial dose of morphine (either with Queensland Ambulance Service or in ED) with ongoing pain score >40mm on the Visual Analogue Scale (VAS) at > 5 minutes post administration of morphine or equivalent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any state (e.g. intoxicated) or medical history (e.g. mental health disorder) impairing accurate pain assessment

Known/suspected to have drug dependence

Allergic to paracetamol
Received or taken paracetamol in the last 6 hours
Known or suspected Renal or hepatic insufficiency
Pregnant
Currently enrolled in other clinical trials for the treatment of pain
Unable to safely swallow oral medication

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)
Eligible participants will be identified and recruited in ED, patients will be allocated according sequentially numbered sealed study packs according to a randomisation list known only to trial pharmacists.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated the drug formulations by a computerized random number generator in a 1:1 allocation ratio. The type of randomization will be simple without stratification
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
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 in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3685 0
The Townsville Hospital - Douglas

Funding & Sponsors
Funding source category [1] 291059 0
University
Name [1] 291059 0
James Cook University
Address [1] 291059 0
1 James Cook Drive, Townsville City QLD 4811
Country [1] 291059 0
Australia
Funding source category [2] 291060 0
Charities/Societies/Foundations
Name [2] 291060 0
Queensland Emergency Medicine Research Foundation
Address [2] 291060 0
2/15 Lang Parade, Milton Qld 4064
Country [2] 291060 0
Australia
Primary sponsor type
Hospital
Name
The Townsville Hospital and Health Service
Address
100 Angus Smith Drive, Douglas QLD 4814
Country
Australia
Secondary sponsor category [1] 289742 0
None
Name [1] 289742 0
nil
Address [1] 289742 0
Country [1] 289742 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292646 0
The Townsville Hospital and Health Service HREC
Ethics committee address [1] 292646 0
100 Angus Smith Drive, Douglas QLD 4814
Ethics committee country [1] 292646 0
Australia
Date submitted for ethics approval [1] 292646 0
Approval date [1] 292646 0
26/11/2014
Ethics approval number [1] 292646 0
HREC/14/QTHS/151

Summary
Brief summary
Randomised control trial of IV and oral paracetamol to assess the efficacy of pain relief. This project could act as a pilot study to form a basis for more extensive research to support the introduction of IV paracetamol for certain ED populations

We hypothesize that patients receiving the IV paracetamol will have a more rapid reduction in pain score, larger reduction in pain scores and require less rescue analgesia than patients in the oral paracetamol group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56390 0
Dr Jeremy Furyk
Address 56390 0
The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814
Country 56390 0
Australia
Phone 56390 0
+617 4433 1111
Fax 56390 0
Email 56390 0
jeremy.furyk@health.qld.gov.au
Contact person for public queries
Name 56391 0
Dr Jeremy Furyk
Address 56391 0
The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814
Country 56391 0
Australia
Phone 56391 0
+617 4433 1111
Fax 56391 0
Email 56391 0
jeremy.furyk@health.qld.gov.au
Contact person for scientific queries
Name 56392 0
Dr Jeremy Furyk
Address 56392 0
The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814
Country 56392 0
Australia
Phone 56392 0
+617 4433 1111
Fax 56392 0
Email 56392 0
jeremy.furyk@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary