Purpose: Effect of local ketamin use in percutaneous nephrolitotomy surgery on post-operation pain reduction and total analgesic consumption.
Inclusion criteria: Paitent undergoing PCNL surgery at Sina hospital. Exclusion criterria: history of mental illness and high blood pressure.
66 patient undergoing PCNL surgery at the end of surgery: one group will receive ketamin 1/5 mg/kg through the nephrostomy tube and group A will not receive the drug.
post-operation pain based on VAS score will be evaluated within the first six hours of the procedure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510083773N16
Registration date:2016-09-05, 1395/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-12-09, 1393/09/18
Expected recruitment end date
2015-12-20, 1394/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of ketamin administration on pain reduction after PCNL surgury
Public title
Ketamin on pain reduction after PCNL surgury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Paitent undergoing PCNL surgery in sina hospital: age 18 to 70.
Exclusion criterria: Addiction, history of mental illness and high blood pressure.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Sina Hospital
Street address
Imam Khomeini Ave,Sina Hospital
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.TUMS.1394.1134
Health conditions studied
1
Description of health condition studied
reduce pain after PCNL surgery
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
pain after surgery
Timepoint
4_6hours after surgery
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: administration 1.5 mg/kg of ketamin at the end of surgery through the nephrostomy tube to renal capsule and under skin.
Category
Treatment - Drugs
2
Description
control group:no intervention on the other group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr.Golnar Shayanpour
Street address
Sina Hospital,Imam khomeini Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Golnar Shayanpour
Street address
Sina Hospital.Imam Khomeini Ave.Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University Of Medical Science
Full name of responsible person
Dr.Golnar Shyanpour
Position
Resident
Other areas of specialty/work
Street address
Sina Hospital,Imam Khomeini Ave
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
Golnar_shayanpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Golnar Shayanpour
Position
Resident
Other areas of specialty/work
Street address
Sina Hospital Imam Khomeini Ave.Tehran
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
Golnar_shayanpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Dr.Golnar Shayanpour
Position
Resident
Other areas of specialty/work
Street address
EmamkhomeiniSt .Hasan Abad Sq .Sina Hospital
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
Golnar_shyanpour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)