Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000146594
Ethics application status
Approved
Date submitted
27/04/2006
Date registered
27/04/2006
Date last updated
27/04/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of ketorolac with morphine in the treatment of acute renal colic
Scientific title
A prospective randomised controlled trial comparing the efficacy of intravenous morphine, intravenous ketorolac and the combination of these medications in acute renal colic in the emergency department
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal colic 1115 0
Condition category
Condition code
Renal and Urogenital 1195 1195 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ketorolac tromethamine - single 30mg intravenous dose
Intervention code [1] 1002 0
Treatment: Drugs
Comparator / control treatment
morphine sulphate - single 10mg intravenous dose
Control group
Active

Outcomes
Primary outcome [1] 1624 0
Pain relief
Timepoint [1] 1624 0
At 10 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours and 6 hours after administration of medication
Secondary outcome [1] 2910 0
Proportion of patients discharged from hospital.
Timepoint [1] 2910 0
At hourly intervals for first 6 hours after administration of medication.

Eligibility
Key inclusion criteria
Able to give informed consentsuspected diagnosis of renal colic on presentation.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or breast feedinghistory of renal impairment (including renal transplant)hepatic impairmentbleeding diathesisactive peptic ulcer diseasehypersensitivity to aspirin or nonsteroidal antiinflammatory drugshypersensitivity to morphinecurrently taking lithium or methotrexatesuspected volume depletion based on clinical examinationnon-English speaking (unfortunately funding limitations make it impossible to provide consent forms and information in languages other than English).

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)
The person who determines if a subject is eligible for inclusion will contact an unblinded worker in the emergency department who will perform randomisation into one of three groups via an internet random number generator (https://randomiser.org/form.htm). This worker will then prepare medications so that they appear identical for administration in a blinded fashion by researchers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generator (http://www.randomizer.org/form.htm) will be used for randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1309 0
Hospital
Name [1] 1309 0
St Vincent's Hospital Emergency Department Budget
Country [1] 1309 0
Australia
Primary sponsor type
Individual
Name
Dr Paul Young
Address
Country
Secondary sponsor category [1] 1156 0
None
Name [1] 1156 0
nil
Address [1] 1156 0
Country [1] 1156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2638 0
St Vincent's Hospital
Ethics committee address [1] 2638 0
Ethics committee country [1] 2638 0
Australia
Date submitted for ethics approval [1] 2638 0
Approval date [1] 2638 0
Ethics approval number [1] 2638 0

Summary
Brief summary
The purpose of this project is to help determine the most effective way to treat the acute pain associated with passage of a kidney stone.

Standard treatment for renal colic involves the use of intravenous morphine titrated to effect. This study will involve comparison of intravenous morphine with ketorolac. This agent is a non-steroidal anti-inflammatory drug which will be given intravenously. In this study, patients will be given morphine, ketorolac or a combination of both of these medications.

The hypothesis that is being tested is that ketorolac provides superior pain relief to morphine in acute renal colic.

This is a double blinded study - both the treating doctors and the patients will be blinded to the interventions administered
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35754 0
Address 35754 0
Country 35754 0
Phone 35754 0
Fax 35754 0
Email 35754 0
Contact person for public queries
Name 10191 0
Dr Paul Young
Address 10191 0
St Vincents Hospital
Fitzroy
Country 10191 0
Australia
Phone 10191 0
92882211
Fax 10191 0
Email 10191 0
[email protected]
Contact person for scientific queries
Name 1119 0
Dr Paul Young
Address 1119 0
c/o Emergency Department
St Vincent's Health
P O Box 2900
Fitzroy
Victoria 3065
Country 1119 0
Australia
Phone 1119 0
(03) 9288 2211
Fax 1119 0
9288 3399
Email 1119 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.