Comparison of analgesic effect of intravenous acetaminophen and morphine
Design
A randomized single blind clinical trial with parallel groups
Settings and conduct
Patients undergoing laparoscopic cholecystectomy in Semnan Kosar Hospital.
Patients will be provided with adequate explanations about each drug and study method before inclusion. Though, they will not know on which regimen they are.
Participants/Inclusion and exclusion criteria
Patients 20-60 years old; undergoing laparoscopic cholecystectomy ; and ASA class I and II; Other than drug addict; and sensitive to drugs used
Intervention groups
Three groups of 20 people included the intravenous acetaminophen group, the morphine group and the intravenous acetaminophen and morphine group
According to ethics, we will have no control group in control of pain
Main outcome variables
Pain control ; morphine complications reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171228038117N1
Registration date:2018-02-07, 1396/11/18
Registration timing:registered_while_recruiting
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Babak Hosseinzadeh zorofchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7838
Email address
babak.hoseinzadeh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intravenous Acetaminophen and Morphine on post Laparoscopic Cholecystectomy pain
Public title
Comparison of analgesic effect of intravenous Acetaminophen and Morphine on post Laparoscopic Cholecystectomy pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under Laparoscopic Cholecystectomy
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Use randomized numbers to allocate patients in 3 blocks (groups)
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be provided with adequate explanations about each drug and study method before inclusion. Though, they will not know on which regimen they have undergone
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Amin Street
City
Semnan
Province
Semnan
Postal code
3515894931
Approval date
2017-12-12, 1396/09/21
Ethics committee reference number
IR.SEMUMS.REC.1396.164
Health conditions studied
1
Description of health condition studied
Post Laparoscopic Cholecystectomy pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post operative pain
Timepoint
Before of operation; After 30 min ; 2,6 and 8 hours after the operation
Method of measurement
Numerical Rating Scale (NRS)
Secondary outcomes
1
Description
Respiratory Rate
Timepoint
30 min, 2,6 and 8 hours after the operation
Method of measurement
Patient's respiratory rate
2
Description
Pulse Rate
Timepoint
30 min, 2,6 and 8 hours after the operation
Method of measurement
Patient's Pulse Rate
3
Description
Blood Pressure
Timepoint
30 min, 2,6 and 8 hours after the operation
Method of measurement
Manometer
4
Description
Needs to additional Morphine
Timepoint
Times to need
Method of measurement
Dosage used
Intervention groups
1
Description
Intervention group 1: Morphine Sulfate 10mg produced by Daroopakhsh, Intra Muscular. Repeat 3 time each 8 hours
Category
Treatment - Drugs
2
Description
Intervention group2:Intra Venus acetaminophen. Tylophen 1g produced by Exir, in 100cc Normal Saline , infusion in 15 minutes. Repeat 3 time each 8 hours
Category
Treatment - Drugs
3
Description
Intervention group3: Morphine and Acetaminophen Intra Venus. Morphine Sulfate 5mg, produced by Daroopakhsh, Intra Muscular and Tylophen 5g produced by Exir, in 100cc Normal Saline , infusion in 7minutes. Repeat 3 time each 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kousar Hospital
Full name of responsible person
Meysam Yousofzade
Street address
Amin Street
City
Semnan
Province
Semnan
Postal code
3515894931
Phone
+98 23 3344 1995
Email
m.yousofzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Meysam Yousofzade
Street address
Amin Street
City
Semnan
Province
Semnan
Postal code
3515894931
Phone
+98 23 3344 1995
Email
m.yousofzade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Meysam Yousofzade
Position
Student(Intern)
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Amin Street
City
Semnan
Province
Semnan
Postal code
3515894931
Phone
+98 23 3344 1995
Email
m.yousofzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Babak Hoseinzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amin Street
City
Semnan
Province
Semnan
Postal code
3515894931
Phone
+98 912 148 1098
Email
babak.hoseinzadeh@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Meysam Yousofzade
Position
Student(Intern)
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Amin Street
City
Semnan
Province
Semnan
Postal code
3515894931
Phone
+98 23 3344 1995
Email
m.yousofzade@yahoo.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