Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000227099
Ethics application status
Approved
Date submitted
15/03/2010
Date registered
18/03/2010
Date last updated
23/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Use of Intravenous Fluids in Acute Ureteric Colic
Scientific title
A prospective, randomised controlled trial on the effect of administration of intravenous fluids compared to minimal fluids on pain scores in acute ureteric colic
Secondary ID [1] 1508 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ureteric Colic 256894 0
Condition category
Condition code
Renal and Urogenital 257042 257042 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To receive 1L normal saline intravenously over 2 hours; further intravenous (IV) fluids can be given only with administration of medications. Analgesic medications given at discretion of clinician.
Intervention code [1] 256093 0
Treatment: Drugs
Comparator / control treatment
IV fluids given only with administration of medications. Analgesic medications given at discretion of clinician.
Control group
Active

Outcomes
Primary outcome [1] 257937 0
Time taken to reach a clinically significant difference in median visual analogue pain scores
Timepoint [1] 257937 0
Measured at 60, 120, 180 and 240 minutes post commencement of treatment.
Secondary outcome [1] 263444 0
Total amount of narcotic analgesia used
Timepoint [1] 263444 0
Taken from the medical record and measured at 60, 120, 180 and 240 minutes post commencement of treatment.
Secondary outcome [2] 263445 0
Length of stay in the Emergency Department
Timepoint [2] 263445 0
Taken from the medical record and measured in minutes until discharge from Emergency Department or admission to Ward/ Short-Stay Observation Unit

Eligibility
Key inclusion criteria
Adult patients (aged 18 or over) who present to the Emergency Depatment with symptoms of acute ureteric colic
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring the acute administration of IV fluids for resuscitation, suspected pyelonephritis, history of congestive cardiac failure, known renal impairment/failure, patients unable to give pain scores (eg. English as a second language, dementia), allergy to non-steroidal anti-inflammatory drugs

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)
All suitable patients will be identified by the Triage nurse who will notify a member of the research team. Participants will be approached by an investigator not involved in the provision of their medical care.
Patients will be randomly allocated to either the experimental (IV fluids) group or control group (no IV fluids) using sealed, sequentially numbered and opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based randomisation tool.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2607 0
3128
Recruitment postcode(s) [2] 2608 0
3135
Recruitment postcode(s) [3] 2609 0
3156
Recruitment postcode(s) [4] 2610 0
Queensland no longer involved

Funding & Sponsors
Funding source category [1] 256584 0
Hospital
Name [1] 256584 0
Box Hill Hospital
Country [1] 256584 0
Australia
Primary sponsor type
Individual
Name
Dr Adeline Wu
Address
c/o Box Hill Hospital Nelson Rd Box Hill VIC 3128
Country
Australia
Secondary sponsor category [1] 255879 0
None
Name [1] 255879 0
Address [1] 255879 0
Country [1] 255879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258616 0
Eastern Health Research and Ethics Committee
Ethics committee address [1] 258616 0
5 Arnold St Box Hill VIC 3128
Ethics committee country [1] 258616 0
Australia
Date submitted for ethics approval [1] 258616 0
24/03/2010
Approval date [1] 258616 0
Ethics approval number [1] 258616 0
E95/0910

Summary
Brief summary
Acute ureteric colic is the pain caused by the passage of kidney stones. Standard treatment is the administration of pain-relieving medications. Intravenous (IV) fluids may also help relieve pain, may cause further pain or have no effect on pain at all. There is a lack of evidence regarding the impact of IV fluids on pain relief in acute ureteric colic. This study hopes to delineate this role by randomising participants with acute ureteric colic into two groups, both of which reflect current practice. The first group will receive IV fluids at a preset rate; the second group will receive IV fluids only with medications. Pain scores via a visual-analogue scale will be taken hourly for up to four hours; these will then be compared to see if there is any clinically significant difference in the pain scores between the two groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30886 0
Address 30886 0
Country 30886 0
Phone 30886 0
Fax 30886 0
Email 30886 0
Contact person for public queries
Name 14133 0
Dr Adeline Wu
Address 14133 0
c/o Emergency Department Box Hill Hospital, Nelson Rd Box Hill VIC 3128
Country 14133 0
Australia
Phone 14133 0
+61 3 9895 3218
Fax 14133 0
Email 14133 0
[email protected]
Contact person for scientific queries
Name 5061 0
Dr Adeline Wu
Address 5061 0
c/o Emergency Department Box Hill Hospital, Nelson Rd Box Hill VIC 3128
Country 5061 0
Australia
Phone 5061 0
+61 3 9895 3218
Fax 5061 0
Email 5061 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.