Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000953932
Ethics application status
Approved
Date submitted
2/09/2011
Date registered
5/09/2011
Date last updated
17/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing time to analgesia in the emergency department using a nurse-initiated pain protocol: a before-and-after study.
Scientific title
In adult patients presenting to the Emergency Department in pain does a nurse-initiated pain protocol compared to usual practice reduce time to analgesia
Secondary ID [1] 262981 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute pain 270703 0
Condition category
Condition code
Other 270881 270881 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nurse-initiated pain protocol in emergency department - involved the administration of various oral analgesic medications (type of drug and dose specified) depending on the patient's pain score (0-10). For example, 2 x paracetamol 500mg oral (or 2 x Ibuprofen 200mg ) for mild pain (pain score 1-3); 2 x paracetamol 500mg with codeine 30mg (or 3 x Ibuprofen 200mg/Codeine 12.8mg) for moderate pain (pain score 4-6), and oxycodone 5mg for severe pain (pain score 7+). The nurse-initiated analgesia protocol could only be used once for each patient without further consultation with a medical officer, ie the duration was for initial pain relief in the Emergency Department only. The nurse-initiated protocol was trialled between 4 April 2009 and 25 June 2009.
Intervention code [1] 269324 0
Treatment: Drugs
Comparator / control treatment
Usual pain management - which requires patient to first be assessed by a medical officer - data collected in the 12 months prior to the intervention ie 2008-2009
Control group
Historical

Outcomes
Primary outcome [1] 279559 0
time to first pain score
Timepoint [1] 279559 0
time interval from time of arrival at triage in ED to time of first pain assessment score (in minutes)
Primary outcome [2] 279560 0
time to analgesia
Timepoint [2] 279560 0
time interval from time of arrival at triage in ED to time of first analgesic drug administered (in minutes)
Secondary outcome [1] 287901 0
adequacy of analgesic effect as defined by Jao et al Emergency Medicine Australasia 2011, 23(2):195-201
Timepoint [1] 287901 0
pain score recorded after first analgesic medication administered

Eligibility
Key inclusion criteria
All adult patients presenting to the ED with pain
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients meeting the following conditions were excluded: presented with chest pain of presumed cardiac origin or headache; were triaged as emergency or urgent (Australasian Triage Score 1 & 2)[12]; exhibited unstable vital signs; were pregnant or lactating; had known contraindications to one of the study drugs; declined analgesia; or already had an analgesia related management plan in place.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Before-and-after study with a historical ('usual practice') control. The intervention was administered to a convenience sample of non-consecutive patients attending the same ED.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/04/2009
Actual
4/04/2009
Date of last participant enrolment
Anticipated
Actual
25/06/2009
Date of last data collection
Anticipated
Actual
25/06/2009
Sample size
Target
288
Accrual to date
Final
889
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 269791 0
Hospital
Name [1] 269791 0
Sir Charles Gairdner Hospital Research Fund
Country [1] 269791 0
Australia
Primary sponsor type
Individual
Name
Professor Judith Finn
Address
Discipline of Emergency Medicine (M516)
The University of Western Australia
35 Stirling Highway
Crawley, 6009, Western Australia
Country
Australia
Secondary sponsor category [1] 268825 0
Individual
Name [1] 268825 0
Dr Roger Swift
Address [1] 268825 0
Emergency Medicine
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands, Western Australia 6009
Country [1] 268825 0
Australia
Other collaborator category [1] 252245 0
Individual
Name [1] 252245 0
Professor Ian Jacobs
Address [1] 252245 0
Discipline of Emergency Medicine (M516)
The University of Western Australia
35 Stirling Highway
Crawley, 6009, Western Australia
Country [1] 252245 0
Australia
Other collaborator category [2] 252246 0
Individual
Name [2] 252246 0
A/Prof Nick Gibson
Address [2] 252246 0
Discipline of Emergency Medicine (M516)
The University of Western Australia
35 Stirling Highway
Crawley, 6009, Western Australia
Country [2] 252246 0
Australia
Other collaborator category [3] 252247 0
Individual
Name [3] 252247 0
Ms Amanda Rae
Address [3] 252247 0
Emergency Medicine
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands, Western Australia 6009
Country [3] 252247 0
Australia
Other collaborator category [4] 252248 0
Individual
Name [4] 252248 0
Ms Tamara Watters
Address [4] 252248 0
Emergency Medicine
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands, Western Australia 6009
Country [4] 252248 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271747 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 271747 0
Ethics committee country [1] 271747 0
Australia
Date submitted for ethics approval [1] 271747 0
27/01/2009
Approval date [1] 271747 0
05/02/2009
Ethics approval number [1] 271747 0
QIA#2226

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

Contacts
Principal investigator
Name 33109 0
Prof Judith Finn
Address 33109 0
School of Nursing, Midwifery & Paramedicine
Curtin University
Kent Street Bentley Western Australia 6102
Country 33109 0
Australia
Phone 33109 0
+ 61 8 9266 4447
Fax 33109 0
Email 33109 0
[email protected]
Contact person for public queries
Name 16356 0
Judith Finn
Address 16356 0
School of Nursing, Midwifery & Paramedicine
Curtin University
Kent Street Bentley Western Australia 6102
Country 16356 0
Australia
Phone 16356 0
+ 61 8 9266 4447
Fax 16356 0
Email 16356 0
[email protected]
Contact person for scientific queries
Name 7284 0
Judith Finn
Address 7284 0
School of Nursing, Midwifery & Paramedicine
Curtin University
Kent Street Bentley Western Australia 6102
Country 7284 0
Australia
Phone 7284 0
+ 61 8 9266 4447
Fax 7284 0
Email 7284 0
[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
No additional documents have been identified.