This study is a double blind randomized clinical trial to survey the efficacy of papaverine in the treatment of acute renal colic. 550 patients with renal colic visited in Rasht Razi Urology Clinic were randomly assigned with block randomization method to receive suppository Diclofenac 100mg or suppository Diclofenac 100mg + papaverine 120mg combined with N/S 0.9% infused intravenously, in 3 minutes. Renal colic pain was compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808251853N4
Registration date:2009-11-16, 1388/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-11-16, 1388/08/25
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Guilan University of Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2010-05-21, 1389/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Papaverine Hydrochloride with Diclofenac Na in the treatment of acute renal colic
Public title
The efficacy of Papaverine Hydrochloride with Diclofenac Na in the treatment of acute renal colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 15-55 years, symptoms of renal colic with any of the followings: hematuria detected by urine analysis, calculi detected by Genitourinary radiography or by sonography.
Exclusion criteria: complete AV block, coronary artery disease, bronchial asthma, peptic ulcer disease, coagulopathy, anticougulat therapy, sensitivity to Dicolofenac or papaverin, renal or liver insufficiency, pregnancy, breast feeding, receiving any analgesics in the past 4 hours.
Age
From 15 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
550
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Science
Street address
Guilan University of Medical Sciences
City
Rasht
Postal code
41448-95655
Approval date
2009-07-14, 1388/04/23
Ethics committee reference number
3092
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
renal colic pain
Timepoint
10 month
Method of measurement
questionairre
Secondary outcomes
empty
Intervention groups
1
Description
Diclofenac Na, 100 mg, suppository plus papaverin 120 mg intravenous
Category
Treatment - Drugs
2
Description
Diclofenac Na, 100 mg, suppository
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Seyyed Alaeddin Asgari
Street address
Razi Hospital, Sardar Jangal street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Dr Abdolrasoul Sobhani- Research Assistant of Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences
City
Rasht
Grant name
معاونت پژوهشي دانشگاه علوم پزشكي وخدمات بهداشتي- درماني گيلان
Grant code / Reference number
10506
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr Mani Mohiti Asl
Position
Co worker/Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc@gums.ac.ir
Web page address
urc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr Seyyed Alaeddin Asgari
Position
Associate Professor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center-Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc@gums.ac.ir; s_a_asgari@gums.ac.ir
Web page address
www.urc.ir
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Secretor of Urology Research Center/Bachlor
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
samaneh_815@yahoo.com; urc@gums.ac.ir
Web page address
www.urc.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)