Methods:Aim of double-blind randomized clinical trial are compared the efficacy of tramadol and diclofenac in the tretment of renal colic.In this study 150 patients with acute renal colic will assessed.The patients devide to 3 groups randomly.The first group give 50mg tramadol (IM),Second group receive 75mg diclofenac (IM) AND The third group(control)give 50 mg pethidine (IV).The pain severity will assessed before and then at 15,30,60 minute after drugs administration,on the base of MacGill questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105293912N3
Registration date:2012-01-15, 1390/10/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-01-15, 1390/10/25
Registrant information
Name
Kobra Nourian
Name of organization / entity
Sharekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
noorian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of Tramadol and Diclofenac in the treatment of renal colic.
Public title
Comparison the efficacy of Tramadol and Diclofenac in the treatment of renal colic.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria :Patients with acute renal colic thats confirm with IVP,KUB.CT-Scan,Sonography.age between 15-65 years
Exclusion Criteria,pregnancy.asthma,allery ,hemorrhagic diseases,drug abuses.
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Shahrekord University of Medical Sciences
Street address
Shahrekord - kashani-Street
City
Shahrekord
Postal code
Approval date
2009-06-26, 1388/04/05
Ethics committee reference number
810
Health conditions studied
1
Description of health condition studied
Renal colic
ICD-10 code
n20-n23
ICD-10 code description
Urolithiasis
Primary outcomes
1
Description
pain
Timepoint
The pain severity will assessed before and then at 15,30,60 minute after drugs administration.
Method of measurement
MacGill questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
50mg pethedin iv(control group)
Category
Treatment - Drugs
2
Description
75mg Diclofenac(IM)
Category
Treatment - Drugs
3
Description
50mg Tramadol(IM)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Kobra Noorian
Street address
Parastar Street
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Saadat Maryam
Street address
Kashani Street
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Noorian Kobra
Position
Lecturer
Other areas of specialty/work
Street address
Kashni Street
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
noorian@skums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Rajaee Mohammad Ali
Position
Assistant professor
Other areas of specialty/work
Street address
Kashani Street
City
Shahrekord
Postal code
Phone
+98 38 1226 4826
Fax
Email
m_rajaee@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Noorian Kobra
Position
Lecturer
Other areas of specialty/work
Street address
Kashani Street
City
Shahrekord
Postal code
Phone
+98 38 1333 5648
Fax
Email
noorian@skums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)