Shivering is a common intra and postoperative problems with a 20%-60% reported incidence. In addition to patient's discomfort, intra and postoperative hypothermia and shivering interfere with patent's monitoring and can increase oxygen consumption and CO2 production. Recently paracetamol have been used at the end of surgery and have been shown to be effective in the prevention of intra and postoperative shivering. The aim of this study is to evaluate the effect of paracetamol in prevention of shivering in patients undergoing to cesarean section with spinal anesthesia with suggestion that prophylactic administration of this agent can prevent inta and postoperative shivering or reduce its severity. After obtaining written informed consent for entering to study, one hundred pregnant patients scheduled for cesarean section, will be enrolled in two groups of 50 and received spinal anesthesia. Case group will be administered infusion of 1000 mg paracetamol in 100 cc normal saline immediately after delivery and the control group will receive normal saline as placebo in the same volume. The incidence and severity of inta and postoperative shivering will be checked and recorded according to Crossley and Mahjon scores. Shivering scores equal to or higher than 3 will be treated with 0.5 mg/kg IV petidine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080710765N7
Registration date:2015-09-15, 1394/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-15, 1394/06/24
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-08, 1394/05/17
Expected recruitment end date
2016-08-08, 1395/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic administration of intravenous Paracetamol for control of shivering during and post cesarean section with spinal anesthesia
Public title
Prophylactic administration of intravenous Paracetamol for control of shivering during and post cesarean section with spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant womenaged between 16 to 45 years old candidate for elective cesarean section with spinal anesthesia; ASA physical class I or II with informed consent for spinal anesthesia. Exclusion criteria: patients with ASA physical class III or higher; contraindication for administration of NSAIDS and paracetamol; peptic ulcer; coagulopathy; renal failure;hepatic failure; fever; any contraindication for performing spinal anesthesia
Age
From 16 years old to 45 years old
Gender
Female
Phase
2-3
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
Vice chancellor for Research of Tabriz University of Medical Sciences
Street address
Vice chancellor for Research, No.2 central building of Tabriz University Of Medical Sciences, Golgasht ave
City
Tabriz
Postal code
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
TBZMED.ERC.1394.275
Health conditions studied
1
Description of health condition studied
Intra and post spinal anesthesia shivering
ICD-10 code
R68.0
ICD-10 code description
Hypothermia, not associated with low enviromental temperature
2
Description of health condition studied
complications of anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Severity of perioperative and postoperative shivering
Timepoint
In recovery every 15 minutes until discharge from recovery
Method of measurement
Crossly and Mahjon five-point scoring system
2
Description
Incidence of intra and post spinal anesthesia shivering
Timepoint
During of surgery and in the recovery room
Method of measurement
visual
Secondary outcomes
1
Description
Need to drug for treatment of shivering
Timepoint
During surgery and in recovery room
Method of measurement
Dose of drug
Intervention groups
1
Description
Intervention group: in this group paracetamol 1000mg in 100 cc normal saline was infused during 15 -20 min after neonatal delivery for prevention of intra and post-operative shivering .
Category
Treatment - Drugs
2
Description
Control group: in this group normal saline iv in same volume intervention group was infused as placebo at 15-20 min after neonatal delivery .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Teaching Hospital
Full name of responsible person
Dr. Sousan Rasooli
Street address
Alzahra Teaching Hospital, Artesh Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Hassan Soleimanpoor
Street address
Vice chancellor for Research,No.2 Vice chancellor for Research,No.2 central building of Tabriz University Of Medical Sciences,golgasht ave
City
Tabriz
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, Tabriz 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
Tabtiz University of Medical Sciences
Full name of responsible person
Sousan Rasouli
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3554 4669
Email
rasooli_s@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Sousan Rasooli
Position
Associate Professor, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
Rasooli_s@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)