The aim of this single blind randomized clinical trial is to campare analgesic effect of acetaminofen codein versus diclofenac sudiom on pain during Extracorporeal Shock Wave Lithotripsy in patients who refer to lithotripsy ward of Shaheed Beheshti hospital.
After signing informed consent, 90 the eligible patients will be assigned randomly three different groups. The acetaminofen codein (A), diclofenac sudiom (B) and no drug (C).
The A group will receive orally 650mg acetaminophen with 20mg codein and B group will receive 50mg diclofenac sudiom one hour before procedure and C group will receive no drug.
Severity of pain assists with Four Point Scale (FPS) before administration of drugs and during procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081711822N6
Registration date:2015-09-05, 1394/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-05, 1394/06/14
Registrant information
Name
Behrooz Karkhanei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0574
Email address
karkhanei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan Univesity of Medical Sciences
Expected recruitment start date
2015-08-16, 1394/05/25
Expected recruitment end date
2015-08-26, 1394/06/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral diclofenac sodium versus acetaminophen codeine on pain during Extracorporeal Shock Wave Lithotripsy (ESWL).
Public title
Analgesic effect of Diclofenac and Acetaminophen in lithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclucion criteria: 18<age<70; ASA<II
Exclusion criteria: History of peptic ulser; G6PD Deficiency; Liver or kidney disease; analgesic agent use 24 hr before lithotripsy; Drug sensitivity; addiction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
SHaheed Fahmideh str. Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2015-08-17, 1394/05/26
Ethics committee reference number
IR.UMSHA.REC.1394 270
Health conditions studied
1
Description of health condition studied
calculus of kidney
ICD-10 code
n20.0
ICD-10 code description
calculus of kidney
Primary outcomes
1
Description
pain
Timepoint
at the time of ESWL and after
Method of measurement
four point scale
Secondary outcomes
1
Description
morphin dose
Timepoint
at the end of ESWl
Method of measurement
dosage
Intervention groups
1
Description
Diclophenac sodium- tablet 50mg-one hour before ESWL
Category
Treatment - Drugs
2
Description
Acetaminophen codein- tablet-300/10mg. no=2, one hour befor ESWL
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mehta Razzaghi
Street address
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behroz Karkhanei
Street address
Shahid Beheshti Hospital of Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mehta Razzaghi
Position
Medical Student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital of Hamedan
City
Hamedan
Postal code
6516953339
Phone
+98 87 3824 6647
Fax
Email
Mehta_razzaghi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behroz karkhanei
Position
Assistant Professor
Other areas of specialty/work
Street address
Hamedan- Shahid Beheshti Hospital
City
Hamedan
Postal code
Phone
+98 81 3838 0704
Fax
Email
Bk13472000@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Farshid Mohammadi
Position
Medical Doctor
Other areas of specialty/work
Street address
Hamedan. Saeidieh str.
City
Hamedan
Postal code
6516953339
Phone
+98 81 3824 6647
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)