Determining the effect of intranasal ketamine on pain intensity after cesarean section
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients. For randomization using random allocation method (table of random numbers) are divided into two groups of intervention and control was performed in Imam Hospital of Sari
Settings and conduct
Patients who meet the inclusion criteria are divided into two groups of intervention and control using the method of random allocation (table of random numbers). The study site is Imam Khomeini Hospital in Sari and only the nurse who prepares the drugs from It will be informed and other personnel including the surgeon and anesthesiologist will not be aware of the two groups studied. The drugs will be similar in volume and appearance. Syringes will be marked with numbers 1 and 2 in sealed envelopes.
Participants/Inclusion and exclusion criteria
Admission requirements: Candidate for non-emergency cesarean section, age between 20-35Conditions of non-entry: patient's unwillingness to continue the study at any time, prolongation of cesarean section (more than 1.5 hours), increase in incision length for any reason, any unusual complications during surgery, unstable vital signs History of Cardiovascular Disease andHypertension, History of Mental Disorders, Known Allergy to Ketamine, History of Drug Addiction
Intervention groups
The intervention group will be given 1 mg / Kg of intramuscular ketamine. The control group will be given normal saline as a placebo intranasally.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211011052726N1
Registration date:2021-11-08, 1400/08/17
Registration timing:retrospective
Last update:2021-11-08, 1400/08/17
Update count:0
Registration date
2021-11-08, 1400/08/17
Registrant information
Name
Nafise Faghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
n.faghani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-02-20, 1399/12/02
Actual recruitment start date
2020-10-22, 1399/08/01
Actual recruitment end date
2021-02-20, 1399/12/02
Trial completion date
2021-02-20, 1399/12/02
Scientific title
The effect of intranasal ketamine on pain intensity after cesarean section
Public title
The effect of intranasal ketamine on pain intensity after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for non-emergency cesarean section
Age between 20-35
Exclusion criteria:
The patient's unwillingness to continue participating in the study at any time
Prolongation of cesarean section (more than 1.5 hours)
Increased incision length for any reason
Occurrence of any unusual complication during surgery
Unstable vital signs
History of cardiovascular disease and hypertension
History of mental disorders
Known allergy to ketamine
History of drug addiction
Age
From 20 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation method (table of random numbers) is divided into two groups of intervention and control. Patients in the intervention group will be given 1 mg / kg of intramuscular ketamine. For the control group, normal saline will be administered intravenously as a placebo. 2 will be identified and sealed in envelopes that only the project nurse who prepares the medication will be aware of, and other staff, including the surgeon and anesthesiologist, will not be aware of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The syringes were similar in volume and shape, and the syringes were identified by the numbers 0 and 2. Was not given to patients as only
The project nurse who prepared the drugs was aware of it, and other staff, including surgeons and anesthesiologists, were unaware of the two groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Mazandaran University of Medical Sciences, Imam Hospital, Sari
Street address
Amir Mazandarani Blvd. Imam Khomeini Educational and Medical Center
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1400.015
Health conditions studied
1
Description of health condition studied
Severe postpartum pain
ICD-10 code
O80
ICD-10 code description
Encounter for full-term uncomplicated delivery
Primary outcomes
1
Description
Intensity of pain
Timepoint
Enter recovery 15, 30, 60 minutes and 2, 6, 12 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
Enter recovery 15, 30, 60 minutes and 2, 6, 12 hours after surgery
Method of measurement
Question from the patient (questionnaire)
Intervention groups
1
Description
Intervention group: One 4 mg tizanidine tablet (made by Galenus) is taken orally one hour before the operation and one tablet 24 hours later.
Category
Treatment - Drugs
2
Description
Control group: A dose of 0.4 mg of clonidine (manufactured by Galenus) is taken orally one hour before the operation and 24 hours after the operation.
Category
Treatment - Drugs
3
Description
Control group: One tablet of 0.4 mg placebo is taken orally one hour before the operation and 24 hours after the operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Nafiseh Faghani Makrani
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
dr.nfaghani@gmail.com
Web page address
https://www.mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saedi
Street address
Moalem Ave
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3325 7230
Fax
+98 11 3325 7230
Email
m.saedi@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
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
Nafiseh Faghani Makrani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
dr.nfaghani@gmail.com
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nafiseh Faghani Makrani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
dr.nfaghani@gmail.com
Web page address
https://www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Nafiseh Faghani Makrani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani Blvd.
City
Sari
Province
Mazandaran
Postal code
48166-33131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
dr.nfaghani@gmail.com
Web page address
https://www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available