Determining and comparing the effect of injectable Acetaminophen with injectable Ketamine by Morphine pump on reducing acute pain after surgery
Design
Double-blind clinical trial with control group, with parallel groups, phase 3 number of 20 on 60 patients. Allocation of samples to intervention groups is done by doctor's order.
Settings and conduct
This study is conducted on patients referred to Shahid Rajaee Hospital who are candidates for various surgeries according to the doctor's orders. Based on the doctor's diagnosis, the patient enters one of the three test groups A (1 mg of Acetaminophen plus 10 mg of Morphine in 100 cc Normal saline at a rate of 4 drops per minute), experimental group B (1 mg of Ketamine plus 10 mg of Morphine in 100 cc of Normal saline at a rate of 4 drops per minute) and the control group (10 mg of Morphine in 100 cc of Normal saline with the speed is 4 drops per minute). The participant and outcome evaluator are blind
Participants/Inclusion and exclusion criteria
Inclution criteria: Patients aged 15 to 60 who are candidates for surgery
Exclusion criteria: Long-term use of Corticosteroids, Antihistamines and painkillers
Allergy to Acetaminophen, Ketamine and Morphine
Intervention groups
Test group A (1 mg of Acetaminophen plus 10 mg of Morphine in 100 cc of Normal saline at a rate of 4 drops per minute), test group B (1 mg of Ketamine plus 10 mg of Morphine in 100 cc of Normal saline at a rate of 4 drops per minute) and the control group (10 mg of Morphine in 100 cc of Normal saline at a rate of 4 drops per minute)
Main outcome variables
The amount of pain after the operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230827059269N1
Registration date:2023-09-24, 1402/07/02
Registration timing:registered_while_recruiting
Last update:2023-09-24, 1402/07/02
Update count:0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Majid Golrezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
m.golrezaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of injectable Acetaminophen with Ketamine injected by Morphine pump on reducing acute pain after surgery
Public title
Comparison of the effect of injectable Acetaminophen with Ketamine injected on reducing acute pain after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 15 to 60 are candidates for surgery
Exclusion criteria:
History of surgery
History of smoking, alcohol and drug abuse
Chronic mental and physical illness (schizophrenia, diabetes, etc.)
Vision and hearing problems and other disabilities
Long-term use of corticosteroids, antihistamines, narcotics and painkillers
Allergy to acetaminophen, ketamine, morphine
Pregnancy and breastfeeding and abortion less than 3 months
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind type of experiment, which will be blind for the people participating in the study and evaluating the outcome. In the consent form to participate in the study, it is written for the patient that his presence does not necessarily mean intervention but may be included in the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of qazvin University of Medical Sciences
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3413996134
Approval date
2022-02-15, 1400/11/26
Ethics committee reference number
IR.QUMS.REC.1400.458
Health conditions studied
1
Description of health condition studied
Acute pain after surgery
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
The amount of pain after the operation
Timepoint
3, 6 and 12 hours after the operation
Method of measurement
Using a ruler-like grading system (Visual Analog Scale) from 0 (no pain) to 10 (the most severe pain imaginable)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In test group A (Acetaminophen drug), after surgery, the patient enters the recovery department, and after fully regaining consciousness and expressing pain, the injection drug Acetaminophen with a dose of 1 mg by an infusion pump by an anesthesiologist as a pain reliever. Analgesic plus 10 mg of Morphine in 100 cc of Normal saline is injected intravenously to the patient at a rate of 4 drops per minute to reduce pain.
Category
Treatment - Drugs
2
Description
Intervention group: In test group B (Ketamine drug), after surgery, the patient enters the recovery department, and after fully regaining consciousness and expressing pain, the injection drug Ketamine with a dose of 1 mg by an infusion pump by an anesthesiologist as a pain reliever. Analgesic plus 10 mg of Morphine in 100 cc of Normal saline is injected intravenously to the patient at a rate of 4 drops per minute to reduce pain.
Category
Treatment - Drugs
3
Description
Control group: In the placebo group, after the surgery, the patient enters the recovery department, and after regaining consciousness and expressing pain, 10 mg of Morphine in 100 cc of Normal saline is injected intravenously at a rate of 4 drops per minute to reduce pain.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Majid Golrezaei
Street address
Safdari Ave., Padegan Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 5800
Email
hosrajaee@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashemi
Street address
Research and Technology deputy ,Mavaddat Alley,Shahid Beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3413996134
Phone
+98 28 3333 7006
Email
researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Majid Golrezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
m.golrezaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Majid Golrezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
m.golrezaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Majid Golrezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar street
City
Qazvin
Province
Qazvin
Postal code
34197-58911
Phone
+98 28 3333 6001
Email
m.golrezaei@gmail.com
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