The aim of this stuy is the assesment of ketamin adding to fentanyl in IV-PCA pumps for control of postoperative pain after laparotomy surgery in the general operating theaters of Hazrat Rasul Akram Hospital.
The inclusion criterias are:
100 Patients age between 20- 60 years, who candidate for abdominal surgery, ASA physical status class I & II,
Exclusion criterias are:
1 - Substance and alcohol abuse
2 - Chronic pain or daily intake housing
3 - Those who do not cooperate
4 - A history of seizures
5 - Liver dysfunction or abnormal liver enzymes
6 - Sensitivity to drugs
The anesthesia technique is the same for patients of two groups.
For induction of anesthesia, thiopental 5 mg/kg, cisatracoriume 0.2 mg/kg and remifentanil 1 µg/kg will be used. For maintenance of anesthesia, propofol 100µg/kg/min and remifentanil 1 µg/kg/min and repeated 2 mg cisatracoriume shall be used every 30 minutes.
Patients will be divided randomly into two groups. In group 1 the IV PCA Pump will be filled with 0.01 mg/ml fentanyl and 0.5 mg/ml ketamine and in group 2 only 0.01 mg/ml fentanyl will be used in pumps. The pumps will be connected to patients in recovery room before exacerbation of pain, maximally up to 2 hours after the end of operation. Then the severity of pain according to VAS will be assessed every 6 hours upto 48 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111128075N1
Registration date:2012-03-27, 1391/01/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-03-27, 1391/01/08
Registrant information
Name
Minoo Sedaghat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 7141
Email address
m-sedaghat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-04-01, 1391/01/13
Expected recruitment end date
2012-07-01, 1391/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adding ketamine to fentanyl patient-controlled analgesia for postoperative pain after laparotomy
Public title
ketamine effect for pain releaf after abdominal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria:
100 Patients age between 20- 60 years, who candidate for abdominal surgery, ASA physical status class I & II,
Exclusion criteria:
1 - Substance and alcohol abuse
2 - Chronic pain or daily intake housing
3 - Those who do not cooperate
4 - A history of seizures
5 - Liver dysfunction or abnormal liver enzymes
6 - Sensitivity to drugs
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Siences
Street address
school of medicine P.O.BOX : 14155-6447
City
Tehran
Postal code
1417613151
Approval date
2011-12-05, 1390/09/14
Ethics committee reference number
42113
Health conditions studied
1
Description of health condition studied
cholelihtiasis
ICD-10 code
K-80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
2
Description of health condition studied
noneinflamatory disorders of ovary
ICD-10 code
N-83.0
ICD-10 code description
Follicular cyst of ovary
Primary outcomes
1
Description
Pain
Timepoint
Every 6 hours until 48 hours after surgery
Method of measurement
VAS (visual analogous scale)
Secondary outcomes
empty
Intervention groups
1
Description
In group 1 the IV PCA Pump will be filled with 0.01 mg/ml fentanyl and 0.5 mg/ml ketamine.
Category
Treatment - Drugs
2
Description
In group 2 only 0.01 mg/ml fentanyl will be used in pumps.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
General operating theaters of Hazrateh Rasul Akram Hospital
Full name of responsible person
Dr Minow Sedaghat
Street address
Sattar-Khan Ave., Niayesh St
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice- Chancellor for Research of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Qods Ave- Central Organization of Tehran University of Medical Sciences- 4th Floor
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
Hazrateh Rasul Akram Hospital, Tehran University of Medical Sciences