Comparision of the effects of adding ketamin or ketorolac to fentanyl for intravenous patient-controlled analgesia on postoperative pain after abdominal hysterectomy
The purpose of this study is to evaluate the effects of adding ketamin or ketorolac to fentanyl for intravenous patient-controlled analgesia on postoperative pain in the women undergoing general anesthesia for abdominal hysterectomy in Shahid Sadoughi hospital in Yazd, Iran. In this randomized double blind trial, 60 women, aged 40-60 years old, and ASA physical status I and II, were assigned into one of the following two groups to receive ,ketamine 0.5 mg/ml or ketorolac 0.6 mg/ml adding to fentanlyl 5 µg/ml via intravenous patient-controlled analgesia after the surgery. Postoperative pain was assessed through visual analog scale (VAS) at 2, 6, 12, and 24 hours after the surgery. Side effects of study drugs (nausea,vomitting,respiratory depression and hallucination) were evaluated during 24 hours and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409132963N20
Registration date:2015-01-08, 1393/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-08, 1393/10/18
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-16, 1393/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of the effects of adding ketamin or ketorolac to fentanyl for intravenous patient-controlled analgesia on postoperative pain after abdominal hysterectomy
Public title
Comparision of the effects of adding two drugs to an opium for intravenous patient-controlled analgesia on postoperative pain after abdominal surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with American Society of Anesthesia (ASA) physical status I or II who are candidate for elective abdominal hysterectomy, age 40-60 years old
Exclusion criteria: patients with BMI>35 and a history of mental impairment,chronic pain,allergic reactions to the study drugs,addiction were excluded.
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Shahid Sadoughi University of Medical Sciences
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2014-09-10, 1393/06/19
Ethics committee reference number
9630
Health conditions studied
1
Description of health condition studied
ketamine
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified
Primary outcomes
1
Description
postoperative pain
Timepoint
2,6,12,24 hours postoperatively
Method of measurement
visual analog pain score
Secondary outcomes
1
Description
side effects(respiratory depression,nausea,vomiting,Hallucination)
Timepoint
2, 6, 12 and 24 hours after operation
Method of measurement
asking the patient, physical examination
Intervention groups
1
Description
in the first group ketamine 0.5 mg/ml is added to fentanlyl 5 µg/ml via intravenous patient-controlled analgesia
Category
Treatment - Drugs
2
Description
in the second group ketorolac 0.6 mg/ml is added to fentanlyl 5 µg/ml via intravenous patient-controlled analgesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Science
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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Shekoufeh Behdad
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+353 8224105
Fax
Email
behdad90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Shekoufeh Behdad
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+353 8224105
Fax
Email
behdad90@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Shekoufeh Behdad
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)