Comparison of analgesic effect of intravenous acetaminophen and ketamine versus intravenous acetaminophen and tramadol in patients undergoing open renal surgeries
The purpose of study is comparison of analgesic effect of intravenous acetaminophen and ketamine versus intravenous acetaminophen and tramadol. The study will be done on 60 patients undergo open renal surgeries. The patients will be divided randomly to two groups. At the end of surgery one group will receive intravenous acetaminophen and ketamine, another group intravenous acetaminophen and tramadol. In the purpose of blinding another physician exception the physician who administers the drug will measure the patients. After the patients arriving the recovery room, outcomes which contain severity of pain based on VAS, amount of agitation based on Richmond Sedation Scale will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509143773N14
Registration date:2016-02-07, 1394/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-07, 1394/11/18
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
2015-10-21, 1394/07/29
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intravenous acetaminophen and ketamine versus intravenous acetaminophen and tramadol in patients undergoing open renal surgeries
Public title
Reduction of post-operative pain using intravenous acetaminophen, ketamine and tramadol in open renal surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Older than 18 years old; With ASA I & II. Exclusion criteria: patients with the history of opium use; history of psychological disorders; chronic low back pain.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Type of randomization= Block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Ghods cross, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-09-12, 1394/06/21
Ethics committee reference number
IR.TUMS.REC.1394.745
Health conditions studied
1
Description of health condition studied
post operation pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
pain
Timepoint
5, 10, and 20 minutes after arriving to the recovery room, to the ward, and also 1 and 6 hours after transfer to the ward.
Method of measurement
Visual Analog Scale
2
Description
level of agitation
Timepoint
5, 10, and 20 minutes after arriving to recovery room, time to transfer from recovery to the ward, and also 1 and 6 hours after transfer to the ward.
Method of measurement
Richmond Sedation Scale
Secondary outcomes
1
Description
Opiom requirment
Timepoint
At recovery room and 6 hour after the surgery
Method of measurement
Submit file
2
Description
patient hemodynamic
Timepoint
5, 10, 20 minutes after the infusion and at exit the recovery room and 6 hour after the surgery
Method of measurement
Blood pressure and pulse rate (Monitoring instrument)
Intervention groups
1
Description
First intervention group: intravenous acetaminophen 1gr and tramadol 0.7mg/kg will be administered At the end of surgery.
Category
Treatment - Drugs
2
Description
Second intervention group: intravenous acetaminophen 1gr and ketamine 0.5mg/kg will be administered at the end of surgery .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Mahdi Saburi
Street address
Sina hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran University of Medical Sciences
Full name of responsible person
Dr Mahdi Saburi
Street address
Sina hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,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 Sciences
Full name of responsible person
Dr Mahdi Saburi
Position
Resident
Other areas of specialty/work
Street address
Sina hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
Pouya.sabouri@gmail.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 Farsad Imani
Position
Professor assistant
Other areas of specialty/work
Street address
Sina hospital Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
imanifar@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mahdi Saburi
Position
Resident
Other areas of specialty/work
Street address
Sina Hospital, Hasanabad Sq., Imam Khomeini St.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
Pouya.sabouri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)