ANZCTR - Registration

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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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

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

Arm 1: paracetamol 1 gram, intravenous as a single dose
Arm 2: paracetamol 1 gram, oral as a single dose

Intervention code [1]

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]

Pain Scores: Visual Analogue Scale

Timepoint [1]

Time of intervention and then at 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes from intervention administration.

Secondary outcome [1]

Patient Satisfaction as assessed on a 5 point Likert scale

Timepoint [1]

At the conclusion of the trial; 4 hours.

Secondary outcome [2]

Adverse Effects such as skin reaction, irritation at injection site, hypotension or other.

Timepoint [2]

Any point throughout the trial from the time of intervention to 4 hours post.

Secondary outcome [3]

Length of Emergency Department stay

Timepoint [3]

Patient discharge or transfer from the Emergency Department

Secondary outcome [4]

Need for rescue analgesia

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

24/04/2015

Actual

24/04/2015

Date of last participant enrolment

Anticipated

Actual

22/02/2016

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Funding & Sponsors

Funding source category [1]

University

Name [1]

James Cook University

Address [1]

1 James Cook Drive, Townsville City QLD 4811

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Queensland Emergency Medicine Research Foundation

Address [2]

2/15 Lang Parade, Milton Qld 4064

Country [2]

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]

None

Name [1]

nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Townsville Hospital and Health Service HREC

Ethics committee address [1]

100 Angus Smith Drive, Douglas QLD 4814

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/11/2014

Ethics approval number [1]

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

Dr Jeremy Furyk

Address

The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814

Country

Australia

Phone

+617 4433 1111

Fax

[email protected]

Contact person for public queries

Name

Jeremy Furyk

Address

The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814

Country

Australia

Phone

+617 4433 1111

Fax

[email protected]

Contact person for scientific queries

Name

Jeremy Furyk

Address

The Townsville Hospital
100 Angus Smith Drive, Douglas QLD 4814

Country

Australia

Phone

+617 4433 1111

Fax

[email protected]

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Intravenous versus oral paracetamol for acute pain in adults in the emergency department setting: A prospective, double-blind, double-dummy, randomised controlled trial.	2018	https://dx.doi.org/10.1136/emermed-2017-206787

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically