The purpose of this study is the comparison of fentanyl and ketorolac with PCA (patient controlled analgesia) pump for post abdominal hysterectomy pain control
Inclusion criteria: 108 patients 20 to 60 years old; ASA I,II
Exclusion criteria: Allergic reaction to Fentanyl or ketorolac
Patients were divided into two groups randomly; the first group receives Fentanyl with PCA Pump and the second group receive Ketorolac with PCA pump the last half hour surgery . then the pain evaluate by VAS(visual analogue scale),The heart rate, respiratory rate, and mean arterial pressure, and sedation score are recorded at 1, 6, 12, 24 hours postoperative.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503288677N5
Registration date:2015-07-09, 1394/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-09, 1394/04/18
Registrant information
Name
Farnoush Farzi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 5624
Email address
farnoush_farzi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of fentanyl and ketorolac with PCA pump for post abdominal hysterectomy pain control
Public title
The comparison of fentanyl and ketorolac with PCA pump for post abdominal hysterectomy pain control .
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Age 20 to 60 years old; ASA I,II
Exclusion criteria: Allergic reaction to Fentanyl or ketorolac
Age
From 20 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
N/A
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
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193893345
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
1930596733
Health conditions studied
1
Description of health condition studied
Hysterectomy
ICD-10 code
O82.2
ICD-10 code description
Delivery by caesarean hysterectomy
Primary outcomes
1
Description
Pain
Timepoint
Baseline ,6 and 12 weeks aftersurgery
Method of measurement
Visual Analog score
2
Description
Sedation
Timepoint
1,6,12,24 hours after surgery
Method of measurement
Sedation score
Secondary outcomes
empty
Intervention groups
1
Description
The first group of pain pumps containing 100 cc (750 mcg of Fentanyl and time-consuming saline) at a rate of 0.4μg / kg / h infusion of Fentanyl that of 30 minutes before the end of the surgery starts.pump started 30 minutes before the end of surgery
Category
Prevention
2
Description
Pain pump in the second group contained 100 cc (90 mg Ketorolac 30mg/ml time-consuming saline) speed
0.05 Ketorolac 30mg/ml in half an hour before surgery begins. Ketorolac 30mg/ml mg / kg / h,
Produced by :Iran hormone factory
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Farnoush Farzi
Street address
Namjoo Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
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 of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Farnoush Farzi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Al-Zahra Hospital
City
Rasht
Postal code
4193713194
Phone
+98 133229524
Fax
+98 32 45132
Email
arcguilan1392@gmail.com; Farnoush_farzi@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Farnoush Farzi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Al-Zahra
City
Rasht
Postal code
4139638459
Phone
+98 133229524
Fax
+98 32 45132
Email
arcguilan1392@gmail.com; farnoush_farzi@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193833697
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)