Effect of low dose Ketamine versus placebo on post-operative pain after cesarean section under spinal anesthesia: a double-blind randomized clinical trial
To assess the effect of low dose Ketamine versus placebo on post-operative pain after cesarean section under spinal anesthesia
Design
This is a double-blind randomized clinical trial, phase III, in which 84 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible women candidate for elective cesarean section referring to the Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients or data analyzer will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 35 years;
Candidate for elective cesarean section;
Gestational age of 36 to 40 weeks;
Exclusion criteria:
History of cardiac disease;
Hypersensitivity to Ketamine;
Renal or liver disease;
Hypertension or hyperthyroidism;
History of convulsion;
Alcohol or drug abuse;
Contraindication of spinal anesthesia;
Psychological disease
Intervention groups
Intervention group:
Intravenous Midazolam 1 mg plus Ketamine (manufactured by Opterop pharmaceutical Co.) 0.5 mg/kg single dose before cesarean section
Control group:
Intravenous Midazolam 1 mg plus normal saline (manufactured by Samen pharmaceutical Co.) 3 ml single dose before cesarean section
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low dose Ketamine versus placebo on post-operative pain after cesarean section under spinal anesthesia: a double-blind randomized clinical trial
Public title
Effect of low dose Ketamine versus placebo on post-operative pain after cesarean section under spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years;
Candidate for elective cesarean section;
Gestational age of 36 to 40 weeks;
Exclusion criteria:
History of cardiac disease;
Hypersensitivity to Ketamine;
Renal or liver disease;
Hypertension or hyperthyroidism;
History of convulsion;
Alcohol or drug abuse;
Contraindication of spinal anesthesia;
Psychological disease
Age
From 13 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The appearance of the medication (Ketamine) and placebo will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.UMSHA.REC.1400.557
Health conditions studied
1
Description of health condition studied
Pain of cesarean delivery wound
ICD-10 code
O90.0
ICD-10 code description
Disruption of cesarean delivery wound
Primary outcomes
1
Description
Pain severity
Timepoint
On 2, 4, and 6 hours after cesarean section
Method of measurement
Using Visual Analog Scale (VAS)
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
On 2, 4, and 6 hours after cesarean section
Method of measurement
Via taking history
2
Description
Vertigo
Timepoint
On 2, 4, and 6 hours after cesarean section
Method of measurement
Via taking history
3
Description
Hypotension
Timepoint
On 2, 4, and 6 hours after cesarean section
Method of measurement
Via physical examination by sphygmometer
Intervention groups
1
Description
Intervention group: Intravenous Midazolam 1 mg plus Ketamine (manufactured by Opterop pharmaceutical Co.) 0.5 mg/kg single dose before cesarean section
Category
Treatment - Drugs
2
Description
Control group: Intravenous Midazolam 1 mg plus normal saline (manufactured by Samen pharmaceutical Co.) 3 ml single dose before cesarean section
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Azadeh Fasihi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
fasihi.azadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Azadeh Fasihi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
fasihi.azadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Davoudi
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mdavoudi10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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