Comparison the effect of Tramadol and Ondansetron in controlling pain and shivering in pregnant women candidate for cesarean section
Design
This three-phase clinical trial, with parallel groups, randomized (using the allocation randomization rule) is performed on 60 pregnant women candidates for elective cesarean section.
Settings and conduct
In this interventional study, 60 pregnant women candidates for elective cesarean section in Yas hospital are selected by convenience sampling.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all pregnant women who are candidates for elective cesarean section with spinal anesthesia. Exclusion criteria: patients with sensitivity to Tramadol or Ondansetron, Emergency cesarean section, and Contraindications to spinal anesthesia.
Intervention groups
After performing spinal anesthesia for the patient, for the intervention, 4 mg of Ondansetron is injected by the anesthesiologist as an intravenous bolus and for the control group, ۰.۵ mg/kg of Tramadol is injected by the anesthesiologist as an intravenous bolus.
Main outcome variables
The patient's shivering and pain after the surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220620055225N3
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Khadijeh Adabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 8217
Email address
kh_adabi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of Tramadol and Ondansetron in controlling pain and shivering in pregnant women candidate for cesarean section
Public title
The controlling pain and shivering in pregnant women candidate for cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women are candidates for elective cesarean section with spinal anesthesia
Exclusion criteria:
Sensitivity to Tramadol or Ondansetron
Emergency cesarean section
Contraindications to spinal anesthesia include intracranial space lesions, systemic or spinal anesthesia puncture site infection, and coagulation disorders
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 30 letters A and 30 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (intervention) or B (control) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed double-blind, the participants and the researcher do not know the type of treatment. For each patient, the appropriate study drug was prepared and diluted (clear and transparent solution) to a volume
of 4 ml (in a 5 ml syringe).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1401.478
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section
Primary outcomes
1
Description
The patient's shivering
Timepoint
Once, after delivery
Method of measurement
Using Tsai and Chu criteria
2
Description
The amount of patient's pain
Timepoint
Once, after delivery
Method of measurement
Using VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After performing spinal anesthesia for the patient, 4 mg of Ondansetron is injected by the anesthesiologist as an intravenous bolus.
Category
Treatment - Drugs
2
Description
Control group: After performing spinal anesthesia for the patient, ۰.۵ mg/kg of Tramadol is injected by the anesthesiologist as an intravenous bolus.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Khadijeh Adabi
Street address
Yas hospital, Next to the Sarv St., North Nejatollahi Str., Karim khan Ave.
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
kh_adabi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Fotouhi
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 6381 9836
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Adabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Blvd., North Nejat Elahi St., Yas Hospital
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Fax
Email
kh_adabi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Adabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Blvd., North Nejat Elahi St., Yas Hospital
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Fax
Email
kh_adabi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Adabi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Karim Khan Blvd., North Nejat Elahi St., Yas Hospital
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 8894 8217
Fax
Email
kh_adabi@sina.tums.ac.ir
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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The anonymous study data is potentially shareable.
When the data will become available and for how long
After the manuscript is published.
To whom data/document is available
No limitations.
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Khadijeh Adabi, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Khadijeh Adabi
What processes are involved for a request to access data/document
Any request must be sent by e-mail with its proposal to Dr. Khadijeh Adabi.