Objectives: To compare the preemptive effect of intravenous Ketorolac versus Meperidine (Pethedine) on shivering and pain after cesarean section surgery under spinal anesthesia. Design: A prospective, randomized, duble-blinded, placebo-controlled clinical trial in Kowsar teaching hospital. Setting and conduct: Tympanic temperature, mean arterial pressure, pulse rate and shivering severity recorded 10 minute before intrathecal injection, end of operation and every 30 minute until 1 hour in recovery room. The 24 hours Post operative Pain severity is classified in numerical scale and analgesic (Apotel) given if needed. First time and total dose of administered analgesic would be compared. Participants: 150 ASA physical status 1, 2 pregnant women, scheduled for elective cesarean section enrolled in this study and excluded if existing history of asthma; peptic ulcer; renal; hepatic or hemorrhagic disease; consumption or history of hypersensivity reaction to Opioid; NSAIDs or other analgesics and MAOIs. Interventions: Patients randomized to three groups: First group 30 mg intravenous Ketorolac (n=50), second group 50 mg intravenous Pethedine (n=50), third group 2 ml Normal saline (n=50). Main outcome measure variables: Shivering and Pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104073051N4
Registration date:2016-04-24, 1395/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-24, 1395/02/05
Registrant information
Name
Marzieh Khezri
Name of organization / entity
Qazvine University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6376
Email address
mkhezri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
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
Comparision of the preemptive effect of Ketorolac (IV) versus Meperidine on shivering and pain after cesarean section under spinal anesthesia
Public title
Comparision of the preemptive effect of Ketorolac (IV) versus Pethidine on shivering and pain after cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women who candidate for elective cesarean section; ASA class 1,2. Exclusion criteria: History of asthma؛ peptic ulcer؛ renal؛ hepatic or hemorrhagic disease؛ Consumption or history of sensitivity reaction to opioid؛ NSAIDs or other analgesics and MAOIs.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
28/20/9850
Health conditions studied
1
Description of health condition studied
Complications predominantly related to the puerperium
ICD-10 code
O89.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during the puerperium
Primary outcomes
1
Description
Shivering
Timepoint
10 minute before anesthesia, end of surgery and every 30 minute until an hour.
Method of measurement
Vision and medical records
2
Description
Pain
Timepoint
Until 24 hours post operation
Method of measurement
VAS (Visual Analogue Scale)
Secondary outcomes
1
Description
Temperature
Timepoint
10 minute before anesthesia, end of surgery and every 30 minute until an hour.
Method of measurement
Thermometriy from tympanic membrane
2
Description
Blood pressure
Timepoint
10 minute before anesthesia, end of surgery and every 30 minute until an hour.
Method of measurement
With manometriy from brachial artery
3
Description
Pulse rate
Timepoint
10 minute before anesthesia, end of surgery and every 30 minute until an hour.
Method of measurement
With monitoring
Intervention groups
1
Description
First group received 50 mg intravenous Meperidine
Category
Treatment - Drugs
2
Description
Second group received 30 mg intravenous Ketorolac
Category
Treatment - Drugs
3
Description
Third group received 2 CC intravenous Normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr. Marziyeh Beigom Khezri
Street address
Kowsar Hospital, Taleghani street, Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Naser Taghi Poor Farivar
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
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 Qazvin University of Medical Sciences