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Trial registered on ANZCTR


Trial ID
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
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
Secondary ID [1] 289925 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chrironex fleckeri (major box jellyfish) stings/envenoming 69 0
Condition category
Condition code
Other 81 81 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hot water immersion at 45 degrees Celsis for 30 minutes
Intervention code [1] 18 0
Treatment: Other
Comparator / control treatment
Ice packs for the same duration (current standard of care)
Control group
Active

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.
Timepoint [1] 113 0
At 30 minutes
Secondary outcome [1] 254 0
Cross-over to the alternate treatment.
Timepoint [1] 254 0
At 30 minutes
Secondary outcome [2] 255 0
Repeat treatment forrecurrent/ongoing pain.
Timepoint [2] 255 0
60 minutes
Secondary outcome [3] 256 0
Use of opiate analgesia.
Timepoint [3] 256 0
at any time
Secondary outcome [4] 257 0
LOS in ED
Timepoint [4] 257 0
this outcome is a time outcome
Secondary outcome [5] 258 0
Development of regional/radiating pain.
Timepoint [5] 258 0
any time after the sting
Secondary outcome [6] 259 0
Frequency of systemic features.
Timepoint [6] 259 0
after the sting
Secondary outcome [7] 260 0
Proportion with recurrent pain.
Timepoint [7] 260 0
At 1hr, 24hr.
Secondary outcome [8] 261 0
Proportion with papular urticaria.
Timepoint [8] 261 0
At 7 to 10 days.

Eligibility
Key inclusion criteria
All patients presenting with a major box jellyfish (Chironex fleckeri) sting.
Minimum age
8 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Open. The treatment allocation will be concealed in the envelope until after the patient has consented to the study
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/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)
NT

Funding & Sponsors
Funding source category [1] 117 0
Government body
Name [1] 117 0
National Health & Medical Research Council Clinical Career Development Award
Address [1] 117 0
NHMRC
Country [1] 117 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research, Charles Darwin University, Darwin
Address
as above
Country
Australia
Secondary sponsor category [1] 86 0
None
Name [1] 86 0
Nil
Address [1] 86 0
Country [1] 86 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 854 0
Royal Darwin Hospital and Menzies School of Health Rersearch
Ethics committee address [1] 854 0
Ethics committee country [1] 854 0
Australia
Date submitted for ethics approval [1] 854 0
30/05/2016
Approval date [1] 854 0
08/07/2005
Ethics approval number [1] 854 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35562 0
Prof Geoffrey Isbister
Address 35562 0
Calvary Mater Newcastle
Waratah NSW 2298
Country 35562 0
Australia
Phone 35562 0
0438466471
Fax 35562 0
Email 35562 0
geoff.isbister@gmail.com
Contact person for public queries
Name 9207 0
Prof Dr Geoffrey Isbister
Address 9207 0
Menzies School of Health Research
PO Box 41096
Casuarina Darwin NT 0811
Country 9207 0
Australia
Phone 9207 0
+61 2 89228888
Fax 9207 0
Email 9207 0
gsbite@ferntree.com
Contact person for scientific queries
Name 135 0
Prof Dr Geoffrey Isbister
Address 135 0
Menzies School of Health Research
PO Box 41096
Casuarina Darwin NT 0811
Country 135 0
Australia
Phone 135 0
+61 2 89228888
Fax 135 0
Email 135 0
gsbite@ferntree.com