Efficacy of prophylactic paracetamol injection for pain reduction after cesarean
Design
Two arm parallel group randomised trial with blinded postoperative care and assesment of pain in them after injection paracetamol or placebo 60 cases
Settings and conduct
We entered 60pregnant women in this study in taleghani hospital .we injected 1gr paracetamol or placebo(normal salin) 30 min before begin of cesaren,we ask severity of pain based on VAS score in 1th,6th,18th and 24 thvhour after cesarean .patients in two groups and questioner have no information of get paracetamol or placeo in each cases.
Participants/Inclusion and exclusion criteria
We entered patients with elective cesarean,single tone pregnancy and gestational age more than38week in this study.we exclude patients wih addiction to drug,cardiac,hepatic and pulmonary disease and allergy to paracetamol from this study
Intervention groups
Pregnant women
Main outcome variables
Severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181001041196N1
Registration date:2019-03-25, 1398/01/05
Registration timing:registered_while_recruiting
Last update:2019-03-25, 1398/01/05
Update count:0
Registration date
2019-03-25, 1398/01/05
Registrant information
Name
Sahar Yahyapourmalekmian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4265 3306
Email address
sahar_yahyapour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of prophylactic paracetamol injection for pain reduction after cesarean
Public title
Efficacy of paracetamol for pain reduction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elective cesarean
Spinal anesthesia
Single tone pregnancy
More than 38weeks pregnancy
Exclusion criteria:
Addiction to drug
Cardiac ,hepatic,pulmonary diseases
Allergy to paracetamol
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomized
Blinding (investigator's opinion)
Double blinded
Blinding description
patients are not aware of their allocation as well as outcome assessors.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of Shahid Beheshti University of Medical Sciences
Street address
Arabai street, velenjak
City
Tehran
Province
Tehran
Postal code
4483131872
Approval date
2018-05-01, 1397/02/11
Ethics committee reference number
IR.SBMU.MSP.REC.1397.698
Health conditions studied
1
Description of health condition studied
Pain localized to other parts of lower abdomen
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
Pain
Timepoint
1 hour after ceassarean,12hour after cesarean ,18hour after cesarean and 24hour after cesarean
Method of measurement
Vas score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: this group includes thirty 38 weeks pregnant women. 1 gr (100 cc) intravenous prophylactic paracetamol (manufactured by Abidi) at one time, 30 minutes before spinal anesthesia, will be administrated in order to reduce the pain after cesarean section.
Category
Prevention
2
Description
Control group: this group includes thirty 38 weeks pregnant women. 100 cc of intravenous prophylactic normal saline as a placebo at one-time, 30 minutes before spinal anesthesia, will be administrated in order to reduce the pain after cesarean section.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Sahar yahyapour
Street address
Arabi street,velenjak
City
Tehran
Province
Tehran
Postal code
٤٤٨٣١٣١٨٧١
Phone
+98 21 2243 9570
Fax
+98 21 2243 9570
Email
Sahar_yahyapour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Ali Ziaee
Street address
Velenjak,erabi street
City
Tehran
Province
Tehran
Postal code
٤٤٨٣١٣١٨٧٢
Phone
+98 21 2243 9572
Fax
+98 21 2243 9573
Email
Sahar_yahyapour@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research deputy of shahid beheshti university of medical sciene
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar yahyapour
Position
Resident of obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 12,sarshar street,valiasr street ,tehran
City
Tehran
Province
Tehran
Postal code
٤٤٨٣١٣٢١٩٨
Phone
+98 21 2243 2525
Email
Sahar_yahyapour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar yahyapour
Position
Resident of obstetrics and gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani hopital, Arabi stret, Velenjak,Tehran
City
Tehran
Province
Tehran
Postal code
6922456167
Phone
+98 21224333306
Email
Sahar_yahyapour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sahar Yahyapour
Position
Assistant specialist of obstetrics and gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Gynecology ward,Arabi street,Velenjak
City
Tehran
Province
Tehran
Postal code
4483131872
Phone
+98 22432525
Fax
+98 21 2243 2526
Email
Sahar_yahyapour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
individual data after removing the identifying variables including name of the patients and file number will be provided for the journal based on the journal policy.
When the data will become available and for how long
6 months after publication the results in the journal.
To whom data/document is available
researchers
Under which criteria data/document could be used
secondary analysis on the primary outcome of the study (pain reduction)
From where data/document is obtainable
Sahar yahyapour
What processes are involved for a request to access data/document
Send an email to Sahar Yahyapour and provide information about the reason for the request and the requested variables. After reviewing the full request of the requesting person or institution, the required data will be sent.