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Trial registered on ANZCTR


Registration number
ACTRN12612000233820
Ethics application status
Approved
Date submitted
9/02/2012
Date registered
23/02/2012
Date last updated
25/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Dermal scarification for the treatment of renal colic.
Scientific title
Dermal scarification versus intramuscular diclofenac sodium injection for the treatment of renal colic. A Prospective Randomised clinical trial.
Secondary ID [1] 279849 0
Nil
Universal Trial Number (UTN)
U1111-1127-8773
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Colic 285737 0
Condition category
Condition code
Renal and Urogenital 285919 285919 0 0
Kidney disease
Anaesthesiology 286068 286068 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endodermal injection (Dermal scarification) of 1ml normal saline at the area of the pain reflection. The injection is administered in participants once only at 8-10 different points intradermally (between the layers of dermis).
Intervention code [1] 284170 0
Treatment: Other
Intervention code [2] 284171 0
Treatment: Drugs
Comparator / control treatment
A single intramuscular injection of 75ml of diclofenac sodium
(Standard treatment). In case of unsuccesful treatment with diclofenac sodium the patients were subjected to dermal scarification. In case of unsuccesful treatment with diclofenac sodium and dermal scarification, the patients were subjected to single IM injection of 50mg Pethidine.
Control group
Active

Outcomes
Primary outcome [1] 286427 0
Renal colic treatment success with dermal scarification.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.
Timepoint [1] 286427 0
At five minutes after scarification.
Primary outcome [2] 286428 0
Renal colic treatment success with diclofenac sodium IM injection.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.
Timepoint [2] 286428 0
At 45 minutes after IM injection.
Secondary outcome [1] 295853 0
Patient's ability to locate with accuracy the exact area of the reflection of pain. When the patient can locate with his index finger the max point of pain reflection.
Timepoint [1] 295853 0
Immediately at presentation.
Secondary outcome [2] 295854 0
Intensity of pain using a ten-point climax before treatment
Timepoint [2] 295854 0
Immediately at presentation
Secondary outcome [3] 295855 0
Intensity of pain using a ten-point climax after treatment with dermal scarification and after treatment with IM injection of Diclofenac Sodium
Timepoint [3] 295855 0
At five minutes after scarification and at 45 minutes after IM injection of Diclofenac Sodium
Secondary outcome [4] 295856 0
How fast each method is effective.If there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.
Timepoint [4] 295856 0
At five minutes after scarification and at 15, 30 and 45 minutes after IM injection of Diclofenac Sodium
Secondary outcome [5] 295857 0
Duration of pain relief after successful treatment. This is assessed if the decrease in the ten point rating scale is maintained.
Timepoint [5] 295857 0
At 15, 30, 45, 60 and 120 min after successful treatment
Secondary outcome [6] 295858 0
In case of unsuccesful treatment with diclofenac sodium, the patients were subjected to dermal scarification. Pain management success.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.
Timepoint [6] 295858 0
At five minutes after scarification
Secondary outcome [7] 295859 0
In case of unsuccesful treatment with diclofenac sodium and dermal scarification, the patients were subjected to IM injection of 50mg Pethidine . Pain management success.
The success of the method is decided according to the patient's answer to the question: Do you think the treatment was helpful in the management of pain?
If the patient answers YES and there is a decrease in the ten point rating scale equal or greater than 5 we consider the treatment successful.
Timepoint [7] 295859 0
At 30 minutes after the IM injection

Eligibility
Key inclusion criteria
1. Patients with typical renal or ureteral colic symptoms and at least two laboratory results that justify the diagnosis (haematuria, positive stone shadow at KUB, ultrasonographic dilation of the upper urinary tract at the side of pain).
2. Written consent of the patient’s participation in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic use of analgesic drugs.
2. Use of any analgesic drug during the last 12hours.
3. Use of anticonvulsant during the last 8 hours.
4. Medical history of allergic reaction to NSAIDs.
5. Medical history of stomach ulcer or gastritis.

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2012
Actual
3/07/2012
Date of last participant enrolment
Anticipated
Actual
4/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment outside Australia
Country [1] 4099 0
Greece
State/province [1] 4099 0

Funding & Sponsors
Funding source category [1] 284680 0
Self funded/Unfunded
Name [1] 284680 0
Country [1] 284680 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 283582 0
None
Name [1] 283582 0
Address [1] 283582 0
Country [1] 283582 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 33717 0
Dr Ioannidis Stavros
Address 33717 0
41 Ethnikis Aminis Street, Thessaloniki, Greece
Country 33717 0
Greece
Phone 33717 0
+302310963104
Fax 33717 0
Email 33717 0
[email protected]
Contact person for public queries
Name 16964 0
Kampantais Spyridon
Address 16964 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 16964 0
Greece
Phone 16964 0
+30 6945375525
Fax 16964 0
Email 16964 0
[email protected]
Contact person for scientific queries
Name 7892 0
Kampantais Spyridon
Address 7892 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 7892 0
Greece
Phone 7892 0
+30 6945375525
Fax 7892 0
Email 7892 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
SourceTitleYear of PublicationDOI
EmbaseDermal scarification versus intramuscular diclofenac sodium injection for the treatment of renal colic: A prospective randomized clinical trial.2014https://dx.doi.org/10.1007/s00240-014-0690-z
N.B. These documents automatically identified may not have been verified by the study sponsor.