Comparison of the Effectiveness of Pretreatment of Dexmedmotidine and Ketorolac on Postoperative Pain in Appendectomy
Design
The sampling method is purposeful and the patients eligible for the study according to entry and exit conditions are studied and then divided into three groups according to the randomized block table obtained by random allocation software.
Settings and conduct
This study is a randomized, double blind clinical trial. After approval by the College of Medicine and Ethics Committee of the University of Medical Sciences all patients aged 18 to 65 years with ASA 1 and 2 who are admitted to apprenticeship at Shahid Mohammadi Bandar Abbas Hospital in 2018 and undergo appendectomy. To be Patients first enter the operating room after being informed by the written consent form attached to it, randomly enter the block into one of the three groups A, B, or C
Participants/Inclusion and exclusion criteria
patients with ASA classification 1&2
18-65 Years old
Intervention groups
Prescribing dexmedetomidine, ketorolac and normal saline for three groups before and during surgery
Main outcome variables
Age
Sex
Weight
Intensity of pain
blood pressure
heart beat
Intervention (drug combination)
The amount of pca content
nausea and vomiting
Shivering
Temperature
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140615018091N9
Registration date:2019-01-10, 1397/10/20
Registration timing:retrospective
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
Fekrat Fereydoon
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 4009
Email address
fereydoon.fekrat@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-03, 1397/05/12
Expected recruitment end date
2018-09-03, 1397/06/12
Actual recruitment start date
2018-08-04, 1397/05/13
Actual recruitment end date
2018-09-12, 1397/06/21
Trial completion date
2018-10-02, 1397/07/10
Scientific title
Comparison of the preemptive effect of Dexmedetomidine and ketorolac on post operative pain of appendectomy
Public title
the preemptive effect of Dexmedetomidine and ketorolac on post operative pain of appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Appendicitis patients with ASA classification 1 & 2
18-65 years old
Exclusion criteria:
History of allergy to any of the drugs used in the study
Patient with ASA classification above two
Addicted patients
Neuropathy or misuse of pain medication
Treatment with analgesics or anti-inflammatory drugs
Pregnancy and lactation
Patients with complicated appendectomy
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The pump syringes were prepared by an expert in the anesthetic room and the assistant did not know its content.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bandar Abbas University of Medical Sciences
Street address
Anesthesiology Research Center, Shahid Mohammadi Hospital, Islamic Republic Blvd.
City
Bandarabbas
Province
Hormozgan
Postal code
7916613885
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.HUMS.REC.1397.047
Health conditions studied
1
Description of health condition studied
post operative pain of appendectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
vas score
Timepoint
at 1, 3, 6, 12 and 24 hours after operation
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
PCA use
Timepoint
at 24 hours after operation
Method of measurement
ml
2
Description
Age
Timepoint
Before entering the study
Method of measurement
ID card
3
Description
Weight
Timepoint
After entering the study and obtaining consent
Method of measurement
kg
4
Description
blood pressure
Timepoint
before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation
Method of measurement
monitoring - mmHg
5
Description
Heart rate
Timepoint
before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation
Method of measurement
monitoring - Number per minute
6
Description
Body temperature
Timepoint
before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation
Method of measurement
Thermometer - C
7
Description
SpO2
Timepoint
before intubation, immediately after intubation, at 5, 10, 15, 20, 30, 40 and every 10 minutes till the end of operation
Method of measurement
Pulse Oxymetry
8
Description
nausea – vomiting
Timepoint
In recovery and 24 hours after surgery
Method of measurement
questionnaire
9
Description
shivering
Timepoint
In recovery and 24 hours after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
The first intervention group received intravenous dexmedetomidine( Precedex (dexmedetomidine hydrochloride) Hospira, Inc. Lake Forest, IL 60045 USA) 1 μg / kg as bolus dose within 10 minutes immediately before induction and then 5 /. Micrograms per kilogram received continuous infusion during surgery.
Category
Treatment - Drugs
2
Description
Intervention group2: Group B received intravenous 30 mg ketorolac before induction
Category
Treatment - Drugs
3
Description
Control group: . Group C was the control group that received normal saline, before induction.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohamadi hospital, Bandar Abbas;IRAN
Full name of responsible person
Fereydoon Fekrat
Street address
Islamic Republic Of Blvd , Shahid Mohammadi Hospital , Bandar Abbas Town , Research Center , Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
fereydoonfekrat@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
AbdulAzim Nejati Zadeh
Street address
Islamic Republic Blvd , Center for Research Vice , Shahid Mohammadi Hospital , Bandar Abbas Town ,Islamic Republic of Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fereydoon Fekrat
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Republic Blvd , Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
fereydoonfekrat@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Republic Blvd , Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Fereydoon Fekrat
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Islamic Republic Blvd , Department of Anesthesiology , Shahid Mohammadi Hospital , Bandar Abbas Town , Islamic Republic of Iran
City
Bandar ABBAS
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
fereydoonfekrat@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
spss
When the data will become available and for how long
1/1/2018
To whom data/document is available
Researchers and referees
Under which criteria data/document could be used
Obtaining a written permit and mentioning the name in the sources
From where data/document is obtainable
fereydoon fekrat
fereydoonfekrat@yahoo.com
What processes are involved for a request to access data/document