Comparison of the effect of preemptive use of both acetaminophen and ketamine in reducing pain after PCNL
Design
This is a double-blind, interventional study with control group. control or intervention group is randomly divided in tow groups. The tow groups will be similar to induction and maintenance of anesthesia.
Settings and conduct
After the approval of the research committee and the Ethics Committee of the Faculty of Medicine and informed consent of patients at Ghaem Hospital and Imam Reza and Mashhad, Central Operations Section, available to patients undergoing PCNL surgery with general anesthesia is selected.
Participants/Inclusion and exclusion criteria
Patients undergoing general anesthesia with PCNL surgery are selected
Intervention groups
Intervention group 1: 0.5 ml / kg injection (2 cc volume) of intravenous ketamine before skin incision + 100 ml normal saline injection in half an hour before anesthesia
Intervention group 2: Inject 1000 milligrams of acetaminophen in 100 cc normal saline intravenous half an hour before anesthesia
Control group: None of the two above drugs is prescribed.
Main outcome variables
scoring of the NVR score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170429033680N11
Registration date:2018-12-27, 1397/10/06
Registration timing:registered_while_recruiting
Last update:2018-12-27, 1397/10/06
Update count:0
Registration date
2018-12-27, 1397/10/06
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-13, 1398/08/22
Actual recruitment start date
2018-11-13, 1397/08/22
Actual recruitment end date
2019-11-13, 1398/08/22
Trial completion date
empty
Scientific title
Comparison of the effects of intravenous ketamine before skin incision with acetaminophen before anesthesia on pain after PCNL surgery
Public title
Comparison of the effects of intravenous ketamine before skin incision with acetaminophen before anesthesia on pain after PCNL surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class one and two
Age between 18 and 70 years
No sensitivity to used drugs
Lack of hypertension and ischemic heart disease
The lack of a known psychiatric illness
Ability to speak and understand Persian
No drug addiction to alcohol
Not taking any analgesic drugs within the last 24 hours
Exclusion criteria:
The creation of surgical complications that make the process turn into action
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table, there is not allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
ِDouble blind study in which subjects under study and the allocation of samples to groups do not know the type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah St, Ghoreish Department .
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.483
Health conditions studied
1
Description of health condition studied
kidney diseases
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
scaling of the NVR score
Timepoint
after surgery
Method of measurement
questionnare
2
Description
pain
Timepoint
after surgery
Method of measurement
VaS score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Injection 0.5 mg / kg (2 cc volume) ketamine before skin incision
Category
Treatment - Drugs
2
Description
Intervention group: inject 1000 milligrams of acetaminophen in 100cc normal saline solution within 15 minutes before skin incision.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical
Full name of responsible person
Mohsen Sabermoghaddam
Street address
Imam Reza Hospital, Square Taghiabad
City
Masshad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
sabermoghaddamm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Daneshgah St, Ghoreishi
City
Mashhad
Province
Razavi Khorasan
Postal code
1394491388
Phone
+98 51 3852 5209
Email
sabermoghaddamm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghaddam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 5209
Email
sabermoghadamm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghaddam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 518525209
Email
sabermoghaddamm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Saber Moghaddam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ghaem Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 518525209
Email
sabermoghaddamm@mums.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
Yes - There is 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
Data file
When the data will become available and for how long
6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Statistical analyzes are permitted in overview articles on delivered data
From where data/document is obtainable
Send an email to sabermoghaddamm@mums.ac.ir
What processes are involved for a request to access data/document