Comparison between Intravenous Acetaminophen (Apotel) and Diclofenac Suppository for Pain Management After elective second Cesarean Section at Imam Khomeini Hospital in Sari
Comparison between Intravenous Acetaminophen (Apotel) and Diclofenac Suppository for Pain Management After elective second Cesarean Section
Design
A clinical trial with a control group, with parallel groups, single-blind, randomized using table of random numbers, on 60 patients.
Settings and conduct
Imam Khomeini hospital in Sari
Participants/Inclusion and exclusion criteria
Women between the ages of 18 and 45 years; Full pregnancy time has passed; No chronic diseases such as cardiovascular, liver and kidney diseases; No drug addiction
Intervention groups
Intervention group 1: Diclofenac. Intervention group 2: Apotel.
Main outcome variables
Patients' vital signs (including respiratory rate, blood pressure, heart rate); nausea/vomiting; VAS ( visual analog scale)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210816052199N1
Registration date:2021-08-31, 1400/06/09
Registration timing:registered_while_recruiting
Last update:2021-08-31, 1400/06/09
Update count:0
Registration date
2021-08-31, 1400/06/09
Registrant information
Name
ََAghdas Ebadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3339 3850
Email address
a.ebadi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-17, 1400/05/26
Expected recruitment end date
2021-10-18, 1400/07/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Intravenous Acetaminophen (Apotel) and Diclofenac Suppository for Pain Management After elective second Cesarean Section at Imam Khomeini Hospital in Sari
Public title
Comparison between Acetaminophen (Apotel) and Diclofenac
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
term pregnancies
without past medical history
without addiction
Exclusion criteria:
allergy history(acetaminophen or local anesthesia agent)
kidney or liver disease
opium addiction
use of painless medicine such as opium or NSAID or corticosteroids
diabets
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting 60 samples with inclusion criteria, the samples will be assigned to two groups by blocking method. The blocking process will be done by random allocation software. With this software, 10 blocks of six will be created and the samples will be entered into study based on the numbers produced by the software.
Blinding (investigator's opinion)
Single blinded
Blinding description
The medicine will be prescribed to the patient by the ward nurse and then the research evaluator will check the effect of the medicine and have no information about the type of medicine the patient is receiving.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Imam khomeini hospital, Razi avenue
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
ir.mazums.rec.1399.192
Health conditions studied
1
Description of health condition studied
Pain control after cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain after cesarean
Timepoint
Every 4 hours for up to 24 hours
Method of measurement
use of visual analog scale(VAS)
2
Description
nausea and vomiting
Timepoint
Every 4 hours for up to 24 hours
Method of measurement
asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: After entering the ward, patients will randomly receive 100 mg diclofenac suppository from Abu Reihan Company and the patient's vital signs and severity of pain, nausea and vomiting will be recorded.If the pain intensity is more than 4, the patient will receive up to three doses of the drug in 24 hours.
Category
Treatment - Drugs
2
Description
Intervention group2: After entering the ward, patients will randomly receive 1000 mg of acetaminophen injected by Daru Pakhsh Company. If the pain intensity is more than 4, the patient will receive up to three doses of the drug in 24 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Aghdas Ebadi
Street address
Imam khomeini hospital, Razi avenue
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
dr.jamkhane@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeidi
Street address
Moallem St.Deputy of Research and Research,
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3448 4854
Email
dr.jamkhane@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Aghdas Ebadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam Khomeini hospital, Razi avenue
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 7100
Email
dr.jamkhane@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebadi Aghdas
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam khomeini hospital, Razi aven
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Email
dr.jamkhane@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebadi Aghdas
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Imam khomeini hospital, Razi aven
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 7100
Email
dr.jamkhane@gmail.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
Part of the data, such as information about the main outcome
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Other than the conditions mentioned above, there is no special condition
From where data/document is obtainable
dr.jamkhane@gmail.com
What processes are involved for a request to access data/document
After receiving the email, information will be sent to them within a maximum period of one month.