1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effects of wound infiltration of combined ketamine and tramadol with solely ketamine and Tramadol on reduction of post-operative pain of pyelolithotomy operation

Protocol summary

Summary
The purpose of study is comparison of the effects of wound infiltration of combined ketamine and tramadol with solely ketamine and Tramadol in patients scheduled pyelolithotomy. Inclusion criteria are scheduled for pyelolithotomy and ASA1-2 and exclusion criteria: Opium addiction; psychologic disease. Study population: patients scheduled pyelolithotomy surgery at Sina hospital. During 1 year, 64 patients over a one-year period will be recruited to 4 groups. One group as control group will receive no drug for prevention of post operative pain. Second group will receive Tramadol, third group Tramadol plus ketamine, forth group ketamine at the edge of the incision of the surgery. At 5/10/15/30 minutes after the exit recovery and 1/3/6/12/24 hours after entrance to the ward pain score will be measured by the visual analogue score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201501243773N12
Registration date: 2015-01-31, 1393/11/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-31, 1393/11/11
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
2013-03-19, 1391/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of wound infiltration of combined ketamine and tramadol with solely ketamine and Tramadol on reduction of post-operative pain of pyelolithotomy operation
Public title
Comparison of combined ketamine and tramadol with solely ketamine and Tramadol on reduction of post-operative pain of pyelolithotomy operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients scheduled pyelolithotomy; ASA1-2. exclusion criteria: Opium addiction; Psychologic disease.
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: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences-Research administration
Street address
Keshavarz Bv. Ghods st. Cross
City
Tehran
Postal code
Approval date
2013-09-29, 1392/07/07
Ethics committee reference number
137645-9011174039

Health conditions studied

1

Description of health condition studied
Post operative pain at pelvic region
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain

Primary outcomes

1

Description
post operative pain
Timepoint
At 5/10/15/30 minutes after the exit recovery and 1/3/6/12/24 hours after entrance to the ward
Method of measurement
visual analogue score

Secondary outcomes

1

Description
agitation / sedation level
Timepoint
5/10/15/30 minutes after the exit recovery
Method of measurement
Richmond Agitation-Sedation Scale

Intervention groups

1

Description
Control group will be received no drug as prevention of post operative pain
Category
Prevention

2

Description
First intervention group: tramadol 0.5% 1 mL
Category
Prevention

3

Description
Second intervention group: tramadol 0.5% 1 mL + ketamine 0.5mg/kg
Category
Prevention

4

Description
Third intervention group: ketamine 0.5mg/kg
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza Khajavi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Masud Yunesian
Street address
Department of Environmental Health Engineering, School of Public Health
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 and Health Services
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 \ Medicine Faculty
Full name of responsible person
Marziyeh Navardi Masule
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
navardi@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
Mohammad Reza Khajavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq.
City
Tehran
Postal code
Phone
+98 21 63120
Fax
Email
khajavim@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
Mohammad Reza Khajavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini St. Hasanabad Sq.
City
Tehran
Postal code
Phone
00
Fax
Email
khajavim@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...