Unique ID issued by UMIN | UMIN000040081 |
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Receipt number | R000045705 |
Scientific Title | Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial. |
Date of disclosure of the study information | 2020/04/07 |
Last modified on | 2020/06/20 04:35:35 |
Treatment of Renal Colic Using intradermal Injection of Sterile Water
ARC
Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.
ISWARC
Asia(except Japan) |
Acute renal colic
Urology |
Others
NO
To evaluate the intracutaneous injection of sterile water in the treatment of renal colic.
Efficacy
Confirmatory
Pragmatic
Not applicable
The primary outcome was the improvement in pain intensity using the visual analogue scale at 30min, 45min, and 60min after ISWI ( intradermal sterile water injection), Diclofenac, Placebo injections
The secondary outcome was the need for rescue analgesia after each modality of therapy.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Treatment
Medicine |
The control group( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5cc isotonic saline in the flank once.
Group A ( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5 cc sterile water in the most painful area of the flank once.
Group B ( 50 patients presented to the emergency department with renal colic ) received an intramuscular injection of 75 mg diclofenac in the gluteal region once.
18 | years-old | <= |
60 | years-old | >= |
Male and Female
Patients presented to the emergency department with acute renal colic, confirmed later on to have ureteral stone on unenhanced Computed tomography (CT scan)
Patients who had an infection in the area of injection, patients more than 60 years old, patients who have received any analgesic before presentation
150
1st name | Athanasios |
Middle name | |
Last name | Papatsoris |
Sismanoglio Hospital.
Urology
15126
Athens, Greece
00302132058001
agpapatsoris@yahoo.gr
1st name | Mohamad |
Middle name | |
Last name | Abou Chakra |
Lebanese University
Urology
1108
Beirut,Lebanon
009611850040ext.3364
mohamedabouchakra@hotmail.com
Al Zahraa Hospital, University Medical Center, Urology Department
None
Self funding
Al Zahraa Hospital, University Medical Center
Beirut,Lebanon
009611850040ext.3366
uro.ul@outlook.com
NO
2020 | Year | 04 | Month | 07 | Day |
Published
10.1016/j.ajem.2020.04.079
150
published
2020 | Year | 04 | Month | 06 | Day |
2020 | Year | 04 | Month | 29 | Day |
Completed
2017 | Year | 12 | Month | 05 | Day |
2017 | Year | 12 | Month | 12 | Day |
2017 | Year | 12 | Month | 15 | Day |
2019 | Year | 12 | Month | 10 | Day |
2019 | Year | 12 | Month | 19 | Day |
2019 | Year | 12 | Month | 20 | Day |
2020 | Year | 01 | Month | 18 | Day |
2020 | Year | 04 | Month | 07 | Day |
2020 | Year | 06 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045705
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