The aim of this study was to evaluate the effect of diclofenac Na supp on postoperative shivering. This was a case double-blind randomized clinical trial study in which 140 women, intervention group received diclofenac Na supp 100mg, ten minutes before induction of anesthesia while control group didn’t receive any medication. Axillary temperatures were measured before induction and 15 minutes after the extubation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902213051N2
Registration date:2011-03-14, 1389/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-03-14, 1389/12/23
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, Qazvin Uniersity of Medical Sciences and Health Services, Iran
Expected recruitment start date
2008-10-31, 1387/08/10
Expected recruitment end date
2009-11-01, 1388/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diclofenac Na supp on postoperative shivering in patients undergoing elective cesarean section surgery
Public title
The effect of diclofenac Na supp on postoperative shivering in patients undergoing elective cesarean section surgery
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, or endocrine disease, addiction to opioids, smocking, consumption of steroids, consumption of NSAIDS or other analgesics
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2011-01-22, 1389/11/02
Ethics committee reference number
3835/20/28
Health conditions studied
1
Description of health condition studied
Other obstetric conditions, not elsewhere classified
ICD-10 code
089
ICD-10 code description
Complications of anaesthesia during the puerperium
Primary outcomes
1
Description
Shivering
Timepoint
One hourse after surgery
Method of measurement
visual
Secondary outcomes
1
Description
temperature
Timepoint
10 minutes before induction of anesthesia and one houres after extubation
Method of measurement
termometr
Intervention groups
1
Description
Intervention: diclofenac Na supp 100mg, ten minutes before induction of anesthesia
Category
Prevention
2
Description
Control group: no medication
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Dr Marziyeh Beigom Khezri
Street address
Kosar hospital, Taleghani Street, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Qazvin University of Medical Science and Health Services
Full name of responsible person
Dr Saeed Assefzadeh
Street address
Shahid Bahonr Blvd, Qazvin
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, Qazvin University of Medical Science 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
Kosar hospital
Full name of responsible person
Dr Marzieh Beigom Khezri
Position
Assistant Professor/Anesthesia
Other areas of specialty/work
Street address
Qazvin,
City
Qazvin
Postal code
3418899581
Phone
+98 28 1222 2452
Fax
+98 28 1223 6378
Email
mkhezri@qums.ac.ir
Web page address
mkhezr88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kosar hospital
Full name of responsible person
Dr Marzieh Beigom Khezri
Position
Assistant Professor/Anesthesia
Other areas of specialty/work
Street address
Kosar hospital, Taleghani Street, Qazvin
City
Qazvin
Postal code
Phone
+98 28 1222 2452
Fax
+98 28 1223 6378
Email
mkhezri@qums.ac.ir
Web page address
mkhezri88@gmail.com
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)