Therapeutic effects of rectal Diclofenac sodium and intramuscular pethedine injection in the treatment of acute renal colic: A randomized clinical trial
Renal colic is a common urological emergency at the emergency department, often caused by the movement of ureteral stones and characterized by severe pain. Patients describe this pain as the most severe and excruciating situation ever experienced this study is conducted to compare the efficacy of analgesic therapy of rectal diclofenac sodium (RD) and intramuscular pethidine (IMP), commonly preferred in emergency departments in our country in patients with renal colic. This study is conducted as a randomized clinical trial. Visual Analog Scale (VAS) would be used to measure primary outcome (pain). All patients with impression of renal stone aging between 17 to 55 will be included in the study. Cases will be divided into two groups randomly (simple randomization). 100 mg suppository Diclofenac will be administered for one group and 50 mg intra muscular Pethedin for another group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408129936N9
Registration date:2014-09-22, 1393/06/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-22, 1393/06/31
Registrant information
Name
Leila Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1623 5586
Email address
lghahraman@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Shiraz, Iran and Jahrom University of Medical Sciences, Jahrom, Iran
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of rectal Diclofenac sodium and intramuscular pethedine injection in the treatment of acute renal colic: A randomized clinical trial
Public title
Therapeutic effects of rectal Diclofenac sodium and intramuscular pethedine injection in the treatment of acute renal colic: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria; all patients with renal colic pain (with impression of renal stone); age between 17 to 55 years old. Exclusion criteria: allergy to NSAIDs; hemorrhoid; anal fissure; acid peptic disease; coagulopathy; pregnancy; heart disease; COPD; liver failure; renal failure.
Age
From 17 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
600
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences, Jahrom, Iran
Street address
Jahrom University of Medical Sciences, Jahrom,Fars, Iran
City
Jahrom
Postal code
-
Approval date
2008-02-20, 1386/12/01
Ethics committee reference number
1386/123
Health conditions studied
1
Description of health condition studied
Renal colic (duo to renal stone)
ICD-10 code
N23
ICD-10 code description
Unspecified renal colic
Primary outcomes
1
Description
The pain score in each group
Timepoint
10, 20, 30 and 60 minutes after using the drug ( intervention)
Method of measurement
Numeric pain intensity scale (VAS Scoring system)
Secondary outcomes
empty
Intervention groups
1
Description
Suppository Diclofenac 100mg stat dose
Category
Treatment - Drugs
2
Description
Pethedin IM 50mg stat dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi hospital, Shiraz University of Medical Sciences
Full name of responsible person
Dr Leila Ghahramani- Assistant professor of General Surgery
Street address
Colorectal Research Center, Shahid Faghihi hospital, Shiraz University of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Seyed Basir Hashemi, MD
Street address
Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Shiraz, Iran
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
Colorectal Research Center, Shiraz university of medical sciences
Full name of responsible person
Leila Ghahramani, MD
Position
Colorectal flowship-assistant professor
Other areas of specialty/work
Street address
Colorectal Research Center, Shiraz university of Medical Siences, Shiraz
City
Shiraz
Postal code
Iran
Phone
+98 71 1230 6972
Fax
Email
leila_ghahramani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Mohammad Mehdi Hosseini, MD
Position
Fellowship of Endourology and Associate Professor of Urology
Other areas of specialty/work
Street address
Endourology ward, Urology Department, Shiraz University of Medical Sciences Shiraz,Iran
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
mmhosseini@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Colorectal Research Center, Shiraz university of medical sciences, Shiraz, Iran
Full name of responsible person
Leila Ghahramani, MD
Position
Colorectal flowship-assistant professor of surgery
Other areas of specialty/work
Street address
Colorectal Research Center, Faghihi hospital, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1230 6972
Fax
Email
leila_ghahramani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)