Comparison of analgesia after injection of ketamine and morphine by pain pump
Design
A clinical trial with parallel double-blind groups was performed on 50 patients after surgery
Settings and conduct
Patients are transferred to recovery under general anesthesia after surgery and are monitored by the pain service. In this case, a 100 ml venous pain control pump is connected to the patient by continuous injection of 5 ml per hour. Patients will be randomly divided into two groups of morphine and ketamine injections after obtaining informed consent. One group of patients will receive low-dose morphine 1 mg / hr and the other group will receive low-dose 3 μg of ketamine. Then at 1, 6, 12 and 24 hours after surgery, patients will be examined for pain scores. If there is a pain score above 3, 10% of the pump is injected intravenously and slowly for 10 minutes and then the patient is monitored for half an hour. Pain intensity is recorded using the VAS scale with a score of 0 to 10 and also qualitatively (low-moderate-severe) before and after drug injection. 24 hours after the operation, the device will be disconnected and the amount of housing used will be recorded. Inclusion criteria include patients who undergo surgery in Khatam Shahroud teaching and medical hospital in 1400. Ages 20 to 60, ASA class two and three.
Participants/Inclusion and exclusion criteria
Existence of significant and uncontrolled underlying disease (hypertension, diabetes, severe renal, hepatic, coagulation disorders, etc.), obesity (weight over 115 kg) History of drug or alcohol addiction
Intervention groups
Ketamine 3Mg/kg/min Morphine 1mg/h
Main outcome variables
pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210509051234N1
Registration date:2021-05-15, 1400/02/25
Registration timing:prospective
Last update:2021-05-15, 1400/02/25
Update count:0
Registration date
2021-05-15, 1400/02/25
Registrant information
Name
Sahar Jamshidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3350 1617
Email address
minoo.ebrahimzadeh1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesia between ketamine infusion and morphine infusion as postoperative pain pump
Public title
Comparison of ketamine and morphine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No underlying disease
no history of drug and alcohol addiction
Exclusion criteria:
hypertension
diabetes
severe renal disorder
obesity
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the medication. The pain score is given by the assessor and the doctor, assessor and patient are blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Shahroud
Street address
next to the gas station,Islamic Azad University ,Shahroud,Semnan
City
shahrood
Province
Semnan
Postal code
4318936199
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1399.036
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score
Timepoint
1-6-12-24
Method of measurement
Asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ketamine 3 microgram/kg/min
Category
Treatment - Drugs
2
Description
Intervention group: morphine 1mg\h
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam o lanbia Hospital
Full name of responsible person
Yahyaii Behrouz
Street address
next to the gas station,Islamic Azad University,Shahroud,Semnan
City
shahrood
Province
Semnan
Postal code
4318936199
Phone
+98 13 3350 2716
Email
minoo.ebrahimzadeh1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Yahyaii.Behrouz
Street address
Next to the gas station,Islamic Azad University,Shahroud,Semnan
City
Shahrood
Province
Semnan
Postal code
4318936199
Phone
+98 13 3350 2716
Email
minoo.ebrahimzadeh1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Researcher
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr.Yahyaii.Behrouz
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Next to the gas station,Islamic Azad University,Shahroud,Semnan
City
Shahrood
Province
Semnan
Postal code
4318936199
Phone
+98 13 3355 2716
Email
Dryousefkolookhianestezi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Kolookhi.Yousef
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Next to the gas station,Islamic Azad University.Shahrood.Semnan
City
Shahrood
Province
Semnan
Postal code
4318936199
Phone
+98 23 3239 0360
Email
Dryousefkolookhianestezi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Yahyaii.Behrouz
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Next to the gas station ,Islamic Azad University,Shahroud,Semnan
City
Shahrood
Province
Semnan
Postal code
4318936199
Phone
+98 23 3239 0360
Email
Dryousefkolookhianestezi@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