This study is a randomized double-blind clinical trial. The aim of this study is comparison of analgesic effects of intraarticular ketamine- methylprednisolone versus methylprednisolone in knee osteoarthritis patients. People under study are 70 patients 35-80 years old with history of at least one month of unsuccessful treatment and positive radiological findings. Patients with a history of drug addiction and fractures of the Knee and meniscal and ligament injuries of the knee will be excluded. Patients are randomly divided into two groups. The first group received ketamine– methylprednisolone. Second group just received methylprednisolone. Patients and doctor are not aware of the content of the injected drug and The drug is prepared by the nurse anesthesia. Orthopedic doctor without a knowledge of the type of drug injected into the joint (Super lateral patellar pouch). The severity of pain in patient were assessed with a visual analog scale one and three months after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111119902N1
Registration date:2015-01-10, 1393/10/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-10, 1393/10/20
Registrant information
Name
Hanoon Sadoni
Name of organization / entity
Ahvaz Jondishapour Univercity Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6504
Email address
sadoni-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effects of intraarticular ketamine- Methylprednisolone and Methylprednisolone in knee osteoarthritis patients
Public title
The Analgesic Effects Of Ketamine- Methylprednisolone versus Methyl Prednisolone in Knee Osteoarthritis Patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pain due to arthritis; at least one month of unsuccessful treatment; positive radiological findings. Exclusion criteria: Pain due to inflammatory diseases; history of fractures of the knee; ankylosis of the knee; previous deformity such as genu varum; immunodeficiency; infection at the injection site; drug addiction; meniscal and ligament injuries of the knee; coagulation disorders.
Age
From 35 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jondishapour University Of Medical Sciences
Street address
Vice chancellor for Research & Technology, Ground floor, central library, Golestan Blvd., Ahvaz Jondishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
Approval date
2014-09-13, 1393/06/22
Ethics committee reference number
Ajums.REC.1393.320
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
Y45
ICD-10 code description
Analgesics, antipyretics and anti-inflammatory drugs
Primary outcomes
1
Description
Pain
Timepoint
One and Three Months After Injection
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Group I: Intra-articular injection of 40 mg/ml methylprednisolone and 1 ml sterile water in the operation room.
Category
Placebo
2
Description
Group II: Intra-articular injection of 40 mg/ml methylprednisolone
and 0.5 mg/kg ketamine in the operating room.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Ali Ghomeishi
Street address
Felestin St., Amanieh, The Razi Hospital, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Office of Vice chancellor for research, Ahwaz Jondishapour University of Medical Sciences, Ground Floor, Central Library, Golestan BLvd., Ahwaz Jondishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahwaz Jondishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Reza Akhondzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, General Operating Room, Second floor of the Imam Khomeini Hospital, Shahid Ahvazian St., Ahwaz
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
Email
akhondzade-r@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Hanoon Sadoni
Position
Specialist in Orthopedic
Other areas of specialty/work
Street address
College of Medicine, Golestan Blvd., Ahvaz Jondishapour University of Medical Sciences, Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
+98 61 3221 6504
Email
sadoni-h@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Sanaz Nazari
Position
Nurse Anesthesia
Other areas of specialty/work
Street address
Pain Research Center, Fourth floor, Imam Khomeini Hospital, Shahid Ahvazian St., Ahvaz
City
Ahvaz
Postal code
6193673166
Phone
+98 61 3221 6504
Fax
Email
s.nz1990@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)