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Comparison of the Effects of Ketorolac and Lidocaine on Reducing Pain During Propofol IV Injection in general anesthesia induction with or without tourniquet

Protocol summary

Study aim
Comparison of the Effects of Ketorolac and Lidocaine on Reducing Pain During Propofol IV Injection in general anesthesia induction with or without tourniquet by Considering the contextual variables , Kosar hospital , Semnan ,2021
Design
Clinical trial, with parallel groups, not blinded, randomized, phase 3 on 120 patients, quadruple permutation block was used for randomization
Settings and conduct
120 patients in Kosar Hospital of Semnan in 1400 is randomly divided into 4 groups. In L1, after injecting 40 mg of lidocaine, wait 30 seconds and inject a quarter of Propofol. In L2, after using the tourniquet, inject Lidocaine, and after 30 seconds, release the tourniquet and immediately inject a quarter of Propofol. In K1, after injecting 10 mg of Ketorolac, we follow L1. In K2, after using the tourniquet, Ketorolac is injected and we act according to L2 group. Finally, pain intensity is assessed based on verbal scoring (VRS) criteria.
Participants/Inclusion and exclusion criteria
Patients with ASA 1 and 2 who have no history of drug, analgesic, or alcohol dependence and are not allergic to Propofol, Lidocaine, and Ketorolac, or who do not have chronic pain syndromes, neurological or psychological disease are eligible for the study. Patients should be able to communicate verbally and not be pregnant.
Intervention groups
L1: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg Lidocaine L2: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg Lidocaine with tourniquet K1: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg Ketorolac K2: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg Ketorolac with tourniquet
Main outcome variables
The severity of immediate pain is assessed based on VRS. Painless (0) Mild pain (1) Moderate pain (2) Severe pain (3)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211101052931N1
Registration date: 2021-12-02, 1400/09/11
Registration timing: registered_while_recruiting

Last update: 2021-12-02, 1400/09/11
Update count: 0
Registration date
2021-12-02, 1400/09/11
Registrant information
Name
Farzaneh Bahmani Motlagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7746 8625
Email address
f.bahmani.98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Ketorolac and Lidocaine on Reducing Pain During Propofol IV Injection in general anesthesia induction with or without tourniquet
Public title
Comparison of the Effects of Ketorolac and Lidocaine on Reducing Pain of Propofol with or without tourniquet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients must be in the American Society of Anesthesiology or ASA Class 1 and 2 . Have the ability to communicate verbally.
Exclusion criteria:
People who are pregnant. Patients with a history of hypnotic, narcotic, or analgesic use in the 24 hours before the surgery or have a history of drug, analgesic, or alcohol dependence Patients who are prohibited from taking Propofol (including allergies to foods such as eggs, soybeans, and Propofol), prohibition of lidocaine or ketorolac, or other nonsteroidal anti-inflammatory drugs (NSAIDs). Patients with chronic pain syndromes, neurological or psychological diseases. Patients who become allergic to drugs during the test.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 30 blocks to select 120 people. We randomly select these blocks from the numbers 1 to 6.Using R software, we choose a random number between the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-BA- A-B-B, respectively. Finally, group 1 and group 2 will be identified
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences - Research and development Vice
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2021-10-31, 1400/08/09
Ethics committee reference number
IR.SEMUMS.REC.1400.185

Health conditions studied

1

Description of health condition studied
Each patient is a candidate for elective surgery who uses Propofol for anesthesia.(Comparison of the Effects of Ketorolac and Lidocaine on Reducing Pain During Propofol IV Injection with or without tourniquet in general anesthesia induction )
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain score in VRS questionnaire
Timepoint
Immediately after intravenous injection of a quarter of Propofol in induction of anesthesia
Method of measurement
Pain intensity is assessed according to the Verbal Rating Scale(VRS)

Secondary outcomes

empty

Intervention groups

1

Description
L1: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg Lidocaine
Category
Treatment - Drugs

2

Description
L2: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 40 mg Lidocaine with tourniquet
Category
Treatment - Drugs

3

Description
K1: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg Ketorolac
Category
Treatment - Drugs

4

Description
K2: Injection of 2 mg / kg Propofol at a rate of 0.5 cc per second after injection of 10 mg Ketorolac with tourniquet
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital in Semnan
Full name of responsible person
Farzaneh Bahmani Motlagh
Street address
Kosar Hospital in Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
http://semums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Koukhaei
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
http://semums.ac.ir
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
Abolfazl Abdollahpoor
Position
Medical Extern
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
http://semums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdollahpoor
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Semnan University Of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
felordce@yahoo.com
Web page address
http://semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdollahpoor
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1022
Fax
+98 23 3343 7837
Email
kosarhos@semums.ac.ir
Web page address
http://semums.ac.ir

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
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