Controlling pain and its complications and reducing the use of narcotic painkillers after surgery
Design
In this study, 88 patients are randomly assigned to two groups, case and control.
Settings and conduct
In this double-blind clinical trial study, all patients who undergo orthopedic surgery at Shahid Beheshti Hospital in Babol are included in the study.
Participants/Inclusion and exclusion criteria
The inclusion criteria: age 20 to 60 years old; lower limb fracture; having consent to enter the study. Exclusion criteria: patients with a history of psychosis and cognitive disorders; patients with a history of drug addiction; pregnant women.
Intervention groups
The case group will receive 0.3 mg/kg (ketamine) half an hour before induction of anesthesia as an intravenous injection, and the control group will receive intravenous infusion of normal saline, as a placebo, in a volume equal to ketamine.
Main outcome variables
Pain; Nausea; Vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221029056333N1
Registration date:2022-11-02, 1401/08/11
Registration timing:prospective
Last update:2022-11-02, 1401/08/11
Update count:0
Registration date
2022-11-02, 1401/08/11
Registrant information
Name
Mehdi Tavasoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
m.tavasoli@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-16, 1401/08/25
Expected recruitment end date
2022-12-16, 1401/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intravenous Ketamine in reducing postoperative pain in lower limb fracture
Public title
Effect of intravenous Ketamine in reducing postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 60 years old
Lower limb fracture
Having consent to enter the study
Exclusion criteria:
Patients with a history of psychosis and cognitive disorders
Patients with a history of drug addiction
Pregnant women
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted randomization block is used. Other blocks are considered 4. In each block, the ratio of ketamine and placebo is equal (1:1). The creation of a random order in each block is done by a statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug injection will be done by an anesthesiologist. The patients and the evaluator (orthopedic resident) are not aware of the title of the text of the drug type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Approval date
2022-10-17, 1401/07/25
Ethics committee reference number
IR.MUBABOL.REC.1401.106
Health conditions studied
1
Description of health condition studied
Lower limb fracture
ICD-10 code
T12
ICD-10 code description
Lower limb fracture
Primary outcomes
1
Description
Pain
Timepoint
In 5 recovery periods, 6 hours, 12 hours and 24 hours after surgery
Method of measurement
Using the VAS scale & record severe pain intensity
Secondary outcomes
1
Description
Nausea
Timepoint
24 hours after surgery
Method of measurement
By N&V benchmark
2
Description
Vomiting
Timepoint
24 hours after surgery
Method of measurement
By N&V benchmark
Intervention groups
1
Description
Intervention group: 0.3 mg/kg (ketamine) is given as an intravenous injection half an hour before induction of anesthesia.
Category
Treatment - Drugs
2
Description
Control group: They will receive an intravenous infusion of normal saline, as a placebo, in a volume equal to that of ketamine.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Mehdi Tavasoli
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
m.tavasoli@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3219 7667
Email
ramazan@yahoo.com
Web page address
http://www.mubabol.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Meysam Mahmodi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
mamodi@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Tavasoli
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
BAbol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Mehdi.tavasolii@gmail.com
Web page address
http://www.mubabol.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Mehdi Tavasoli
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Babol University of Medical Sciences; Ganjafrooz Street; Babol; Iran
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3225 6285
Email
Mehdi.tavasolii@gmail.com
Web page address
http://www.mubabol.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD