Comparison of the effectiveness of intramuscular injection of Ketorolac with PCA pump Containing Morphine and Apotel in Pain control of Patients after Cesarean Section
Comparison of the effectiveness of intramuscular ketorolac with PCA pump containing morphine and Apotel in pain control of patients after cesarean section.
Design
Clinical trial with parallel groups, double-blind, randomized, phase 2 on 90 patients. For randomization, block method and homogenization of blocks of four were used
Settings and conduct
This study was conducted on pregnant mothers scheduled for elective caesarean section under general anesthesia at Valiasr Hospital in Birjand, with no exclusion criteria. After surgery, patients were given pain assessments using a visual pain score 15 minutes after entering the recovery room. They were then divided into two groups:
1. Group A: Patients received a deep intramuscular injection of 30 mg if they weighed under 50 kg or 60 mg if they weighed over 50 kg of a medication, repeated every 8 hours.
2. Group B: Patients received a combination of 0.5 mg/kg of morphine and 40 mg/kg of Apotel through an anesthesia pump.
Pain assessments were conducted at 6, 12, and 24 hours after the operation, and patients' responses were recorded. Additionally, the patients were examined for any adverse side effects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant mothers aged 20-40 years with ASA class 1-2 with a gestational age of at least 37 weeks; candidates for elective cesarean section with a transverse incision.
Exclusion criteria:
coagulation disorders; Receiving NSAID and narcotics before surgery; BMI more than 30.
Intervention groups
Group A (receiver of intramuscular ketorolac) and group B (receiver of PCA pump containing morphine and Apotel)
Main outcome variables
Average pain intensity of patients ؛ average hemodynamic indices ؛ frequency distribution of side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231005059625N1
Registration date:2023-10-25, 1402/08/03
Registration timing:prospective
Last update:2023-10-25, 1402/08/03
Update count:0
Registration date
2023-10-25, 1402/08/03
Registrant information
Name
Mersede Faghihshojaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 5000
Email address
m.faghihshojaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of intramuscular injection of Ketorolac with PCA pump Containing Morphine and Apotel in Pain control of Patients after Cesarean Section
Public title
Comparison of the effectiveness of intramuscular injection of Ketorolac with PCA pump Containing Morphine and Apotel in Pain control of Patients after Cesarean Section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers, 20-40 years old,
Elective caesarean section with transverse incision
Pregnancy age at least 37 weeks
American Society of Anesthesiology based on II and I ASA class
Exclusion criteria:
Suffering from gestational hypertension
Receiving NSAID and narcotics before surgery
Mothers of macrosomic and multiple babies
Spinal or epidural anesthesia method
history of peptic ulcer
history of coagulation disorders
BMI more than 30
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In order to enter the study, the basic information of the patient is recorded in the relevant forms. The referring patients were divided into two groups A (recipients of intramuscular ketorolac) and group B (recipients of PCA pump containing morphine and Apotel) by a simple random block method and homogenization of quadruple blocks (BAAB, ABBA, BABA, ABAB, BBAA, AABB).
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to blind the mothers, they will be aware of the generalities of the research, which is the creation of analgesia by drugs, but they will not know about the method of prescribing drugs based on the groups under study. 15 minutes after entering the recovery room and before the intervention to create analgesia, the patient's pain is measured and recorded based on the visual pain score (VAS). Then, for the patients 6, 12 and 24 hours after the operation, the questionnaire is completed by one of the trained nurses who is not part of the research team and is not aware of the groups under study. (It should be noted that in the patient questionnaire, the type of prescription drug is mentioned as group A and group B, and the nurse entering the data is not aware of the type of prescription drug.)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Birjand University of Medical Sciences
Street address
Ghaffari Blvd, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Approval date
2023-09-25, 1402/07/03
Ethics committee reference number
IR.BUMS.REC.1402.278
Health conditions studied
1
Description of health condition studied
Painlessness after surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination and comparison of the average pain intensity of the patients after the cesarean section in the group receiving intramuscular ketorolac and the group receiving morphine and Apotel by PCA pump
Timepoint
, 15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the cesarean section
Method of measurement
Visual pain score(Visual Analogue Scale)
Secondary outcomes
1
Description
The mean of hemodynamic indices (average blood pressure, heart rate and SPO2).
Timepoint
15 minutes after the operation (before intervention for analgesia) and 6, 12 and 24 hours after the operation
Method of measurement
Automatic monitoring device
2
Description
Frequency distribution of mothers' need to receive an additional dose of anesthesia
Timepoint
In the first 24 hours after the operation
Method of measurement
Based on the history of the patient
3
Description
Frequency distribution of side effects (nausea, vomiting, abnormal sleepiness, respiratory depression, stomach pain)
Timepoint
In the first 24 hours after the operation
Method of measurement
Based on the history of the patient
Intervention groups
1
Description
Intervention group1: Intervention Group: In the intervention group, an Optofuser analgesia pump from Darman Gostar Sepano in Iran was used. This pump had a capacity of 100 cc and operated at a speed of 4 cc per hour. A bolus dose of 0.5 cc could be administered with a 15-minute lockout period. The medication administered through this pump consisted of 0.5 mg per kilogram of morphine combined with 40 mg per kilogram of Apotel, and it was diluted with normal saline to reach a total volume of 100 cc.
Category
Treatment - Drugs
2
Description
Intervention group2: Intervention group: Ketorolac, 30 mg in people under 50 kg and 60 mg in people over 50 kg as a deep intramuscular injection that is repeated every 8 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Mersede Faghih Shojaei
Street address
Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3162 2000
Fax
+98 56 3163 5801
Email
amoozesh@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Yousefi
Street address
Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Fax
+98 56 3238 1220
Email
masoud.yousefi@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Mersede Faghihshojaei
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghaffari blv - Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3238 5000
Fax
Email
m.faghihshojaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mersede Faghihshojaei
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghaffari blv - Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3238 5000
Fax
Email
m.faghihshojaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mersede Faghihshojaei
Position
Medical intern
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ghaffari blv - Birjand university of medical science
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3238 5000
Fax
Email
m.faghihshojaei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Protocol for the treatment of pain after cesarean section
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Researchers of all disciplines
Under which criteria data/document could be used
After the publication of the article
From where data/document is obtainable
m.faghihshojaei@gmail.com
What processes are involved for a request to access data/document