The Effect of various dosages of Ketamin on postoperative pain in opiate-dependent patients undergoing radius distal, femur, and tibia fracture orthopedic surgery
Investigating the effectiveness of different doses of ketamine on postoperative pain in drug addicts undergoing orthopedic surgery for fractures of the distal radius, femur, and tibia
Design
A clinical trial with a control group, with parallel groups, 1 blind, randomized, phase 0 on 50 patients. The rand function of Excel software was used for randomization
Settings and conduct
Patients with a history of drug abuse, aged 18-65 years old, were referred to Shahid Beheshti Hospital in Kashan in 1401 for orthopedic surgery due to distal radius trauma of the upper limb and fractures of the femur and tibia of the lower limb.
Participants/Inclusion and exclusion criteria
Patients with a history of drug abuse aged 18-65 (18 to 65 years were chosen to minimize the possibility of age-related mood disorders) are the age to undergo orthopedic surgery due to trauma to the distal radius of the upper limb and bone fracture. The lower limb femur and tibia were referred to Shahid Beheshti Hospital in Kashan in 1401.
Exclusion criteria:
Patients with multiple traumas, consumption of alcohol, and artificial drugs not derived from opium
Patients who continuously use drugs other than narcotics
The patient's lack of consent for the study or the patient's lack of cooperation after entering the study
History of seizures or drug sensitivity to ketamine and other contraindications to ketamine
History of cardiovascular diseases
Intervention groups
First group ketamine 1 mg/kg
The second group received 0.5 mg/kg in the third group, normal saline as a placebo at the beginning of the surgical incision.
Main outcome variables
pain intensity score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230804059031N1
Registration date:2023-11-26, 1402/09/05
Registration timing:registered_while_recruiting
Last update:2023-11-26, 1402/09/05
Update count:0
Registration date
2023-11-26, 1402/09/05
Registrant information
Name
Ali Khandan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 163 2580
Email address
khandan.dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-05, 1402/08/14
Expected recruitment end date
2023-12-05, 1402/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of various dosages of Ketamin on postoperative pain in opiate-dependent patients undergoing radius distal, femur, and tibia fracture orthopedic surgery
Public title
The Effect of Various dosage of Ketamin on postoperative pain in opiate-dependent patients undergoing orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of drug abuse
18-65 years
Exclusion criteria:
Patients with multiple trauma
Consumption of alcohol and artificial drugs not derived from opium
Patients should have continuous use of drugs other than narcotics
Lack of patient consent for the study
Non-cooperation of the patient after entering the study
History of seizures or drug sensitivity to ketamine and other contraindications to ketamine
History of cardiovascular diseases
Age
From 18 years old to 6 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning people will be the "Permuted Block Randomization" method. In this way, gradually and in the order of referral for surgery, for all three patients who will be referred, in advance by randomly selecting one of the following blocks using the table of random numbers (numbers 1 to 6) the desired sequence for the block of three The next three patients will be selected. sequence of blocks and corresponding numbers;
1) ABC 2) ACB 3) BAC 4) BCA 5) CAB 6) CBA
A, 1mg/kg ketamine,
B, 0.5 mg/kg ketamine
C, normal saline
A total of about 24 sequences will be selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کارگروه/ کمیته اخلاق در پژوهش دانشکده پزشکی و دندانپزشکی- دانشگاه علوم پزشکی کاشان
Street address
56 Hekmat, Qutub Rawandi Boulevard, Kashan, Isfahan Province
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2022-08-21, 1401/05/30
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.089
Health conditions studied
1
Description of health condition studied
Upper and lower limb fractures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Investigating the effectiveness of different doses of ketamine on postoperative pain in drug addicts undergoing orthopedic surgery for fractures of the distal radius, femur and tibia.
Timepoint
2, 6, 12 and 25 hours after the operation
Method of measurement
1 to 10
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 1mg/kg/ ketamine/C13H16ClNO/intravenous and at the beginning of surgical incision/1 shift/made by Rotex Germany company/
Category
Treatment - Drugs
2
Description
Intervention group 2: 0.5 mg/Ketamine/C13H16ClNO/kg/intravenous and at the beginning of surgical incision/1 shift/made by German Rotex company
Category
Treatment - Drugs
3
Description
Intervention group3: normal saline/SODIUM CHLORIDE 0.9percent /intravenous and at the beginning of surgical incision/1 turn/manufactured by Iran Injectable and Pharmaceutical Products Company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شهید بهشتی
Full name of responsible person
Ali Khandan
Street address
استان اصفهان، کاشان، بلوار علامه قطب راوندی
City
Kashan
Province
Isfehan
Postal code
81151/87159
Phone
+98 31 5554 0026
Email
khandan.dr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Kashan - Qutb Rawandi Boulevard - Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9007
Email
hamiidi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Ali Khandan
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
بلوار امام رضا ، نبش بلوار،جنب سوپر پروتئین کاشان
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 913 163 2580
Fax
Email
khandan.dr@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Khandan
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
بلوار امام رضا ، نبش بلوار،جنب سوپر پروتئین کاشان
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 913 163 2580
Fax
Email
khandan.dr@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Khandan
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
بلوار امام رضا ، نبش بلوار،جنب سوپر پروتئین کاشان
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 913 163 2580
Fax
Email
khandan.dr@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only a part of the data, such as the information related to the main result or the like, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no other conditions for the use of data or documentation
From where data/document is obtainable
Ali Khandan
What processes are involved for a request to access data/document
After the initial review of the request, it will be sent to them within a month