Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12605000007639
Ethics application status
Approved
Date submitted
13/07/2005
Date registered
13/07/2005
Date last updated
11/08/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
A randomised controlled trial of hot water (45.C) immersion versus ice packs for Chironex fleckeri stings
Query!
Scientific title
A randomised controlled trial of hot water (45.C) immersion versus ice packs to reduce pain by a clinically significant amount on a visual analogue score in chironex fleckeri stings
Query!
Secondary ID [1]
289925
0
Nil Known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chrironex fleckeri (major box jellyfish) stings/envenoming
69
0
Query!
Condition category
Condition code
Other
81
81
0
0
Query!
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Hot water immersion at 45 degrees Celsis for 30 minutes
Query!
Intervention code [1]
18
0
Treatment: Other
Query!
Comparator / control treatment
Ice packs for the same duration (current standard of care)
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
113
0
A reduction in pain defined on the visual analogue score (VAS) as "much better" or clinically significant according to a modification of Bird and Dickson.
Query!
Assessment method [1]
113
0
Query!
Timepoint [1]
113
0
At 30 minutes
Query!
Secondary outcome [1]
254
0
Cross-over to the alternate treatment.
Query!
Assessment method [1]
254
0
Query!
Timepoint [1]
254
0
At 30 minutes
Query!
Secondary outcome [2]
255
0
Repeat treatment forrecurrent/ongoing pain.
Query!
Assessment method [2]
255
0
Query!
Timepoint [2]
255
0
60 minutes
Query!
Secondary outcome [3]
256
0
Use of opiate analgesia.
Query!
Assessment method [3]
256
0
Query!
Timepoint [3]
256
0
at any time
Query!
Secondary outcome [4]
257
0
LOS in ED
Query!
Assessment method [4]
257
0
Query!
Timepoint [4]
257
0
this outcome is a time outcome
Query!
Secondary outcome [5]
258
0
Development of regional/radiating pain.
Query!
Assessment method [5]
258
0
Query!
Timepoint [5]
258
0
any time after the sting
Query!
Secondary outcome [6]
259
0
Frequency of systemic features.
Query!
Assessment method [6]
259
0
Query!
Timepoint [6]
259
0
after the sting
Query!
Secondary outcome [7]
260
0
Proportion with recurrent pain.
Query!
Assessment method [7]
260
0
Query!
Timepoint [7]
260
0
At 1hr, 24hr.
Query!
Secondary outcome [8]
261
0
Proportion with papular urticaria.
Query!
Assessment method [8]
261
0
Query!
Timepoint [8]
261
0
At 7 to 10 days.
Query!
Eligibility
Key inclusion criteria
All patients presenting with a major box jellyfish (Chironex fleckeri) sting.
Query!
Minimum age
8
Years
Query!
Query!
Maximum age
Not stated
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Severe envenoming requiring resuscitation or antivenom, a sting clinically consistent with Irukandji syndrome and not C. fleckeri, stings to the eye, an initial abnormal ECG, initial hypotension: Systolic BP <90mmHg
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open. The treatment allocation will be concealed in the envelope until after the patient has consented to the study
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised by computer in sequentially numbered envelopes in variable block sizes.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/10/2005
Query!
Actual
27/11/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
25/10/2008
Query!
Date of last data collection
Anticipated
Query!
Actual
30/10/2008
Query!
Sample size
Target
55
Query!
Accrual to date
Query!
Final
46
Query!
Recruitment in Australia
Recruitment state(s)
NT
Query!
Funding & Sponsors
Funding source category [1]
117
0
Government body
Query!
Name [1]
117
0
National Health & Medical Research Council Clinical Career Development Award
Query!
Address [1]
117
0
NHMRC
Query!
Country [1]
117
0
Australia
Query!
Primary sponsor type
University
Query!
Name
Menzies School of Health Research, Charles Darwin University, Darwin
Query!
Address
as above
Query!
Country
Australia
Query!
Secondary sponsor category [1]
86
0
None
Query!
Name [1]
86
0
Nil
Query!
Address [1]
86
0
Query!
Country [1]
86
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
854
0
Royal Darwin Hospital and Menzies School of Health Rersearch
Query!
Ethics committee address [1]
854
0
Query!
Ethics committee country [1]
854
0
Australia
Query!
Date submitted for ethics approval [1]
854
0
30/05/2016
Query!
Approval date [1]
854
0
08/07/2005
Query!
Ethics approval number [1]
854
0
Query!
Summary
Brief summary
The study was completed about 7 years ago but due to a lack of funding and two investigators not being on site it has not been analysed. The study now has been analysed and will be presented in November 2016.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
35562
0
Prof Geoffrey Isbister
Query!
Address
35562
0
Calvary Mater Newcastle
Waratah NSW 2298
Query!
Country
35562
0
Australia
Query!
Phone
35562
0
0438466471
Query!
Fax
35562
0
Query!
Email
35562
0
[email protected]
Query!
Contact person for public queries
Name
9207
0
Dr Geoffrey Isbister
Query!
Address
9207
0
Menzies School of Health Research
PO Box 41096
Casuarina Darwin NT 0811
Query!
Country
9207
0
Australia
Query!
Phone
9207
0
+61 2 89228888
Query!
Fax
9207
0
Query!
Email
9207
0
[email protected]
Query!
Contact person for scientific queries
Name
135
0
Dr Geoffrey Isbister
Query!
Address
135
0
Menzies School of Health Research
PO Box 41096
Casuarina Darwin NT 0811
Query!
Country
135
0
Australia
Query!
Phone
135
0
+61 2 89228888
Query!
Fax
135
0
Query!
Email
135
0
[email protected]
Query!
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
Hot water immersion v icepacks for treating the pain of Chironex fleckeri stings: A randomised controlled trial.
2017
https://dx.doi.org/10.5694/mja16.00990
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF