Investigating the effect of oxazepam on drug abuse reduction
Design
Randomization method In this study, the use of random blocks with quadruple blocks after random sequencing of this list was carried out using encapsulated packets. Finally, 90 envelopes containing the random sequences of each patient were provided to the original researcher. Took The process of random allocation and hiding the list was carried out by one of the authors who did not participate in the process of selecting, treating, collecting information
Settings and conduct
The location of the study of Shahid Rajaee Hospital of Qazvin Orthopedic section will be Patients with leg fractures requiring plate after signing the consent form are not aware of being in the control or intervention group
Participants/Inclusion and exclusion criteria
. Inclusion criteria include ages 20 to 60 years; candidates for orthopedic surgeries of the lower extremities; exclusion criteria including chronic renal failure; heart disease; alteration in consciousness; mental illness; diabetes; history of surgery; peripheral neuropathy; anemia; history of allergy to the drugs used in the study; history of using hypnotics; patients with poor collaboration; history of NSAIDS and drug abuse
Intervention groups
In the control group, after admission, the patient receives the drug as needed, but in the intervention group, in addition to receiving the opioid receptacle, he receives the ozoxapam tablet as needed
Main outcome variables
Reducing drug use in the intervention group
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20161031030609N2
Registration date:2017-12-06, 1396/09/15
Registration timing:registered_while_recruiting
Last update:2017-12-06, 1396/09/15
Update count:0
Registration date
2017-12-06, 1396/09/15
Registrant information
Name
Marzieh Asghari
Name of organization / entity
Rajaei Cardiovascular Research Center
Country
Iran (Islamic Republic of)
Phone
+98 28 3222 4667
Email address
asghary_marzieh@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2017-11-06, 1396/08/15
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of oxazepam administration on the amount of opioids consumption in patients after lower limb orthopedic surgeries
Public title
Assessment the effect of oxazepam administration on the pain of past orthopedic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 60 years old
candidate for orthopedic surgeries of the lower extremities
tend to Participate study
Exclusion criteria:
history of chronic renal failure
heart disease
abnormal consciousness
having mental illness
diabetes
history of surgery
peripheral neuropathy
anemia
History of allergy to the drugs used in the study
the history of using hypnotic drugs
poorly performing patients
history of NSAIDS
abuse opiode
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method In this study, the use of random blocks with quadruple blocks after random sequencing of this list was carried out using encapsulated packets. Finally, 90 envelopes containing the random sequences of each patient were provided to the original researcher. Took The process of random allocation and hiding the list was carried out by one of the authors who did not participate in the process of selecting, treating, collecting information
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant will not be informed of the group after signing the consent form
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd. Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2017-09-28, 1396/07/06
Ethics committee reference number
IR.QUMS.REC.1396.289
Health conditions studied
1
Description of health condition studied
Orthopedic
ICD-10 code
M95-M99
ICD-10 code description
بیماری های عضلانی اسکلتی
Primary outcomes
1
Description
reduce pain
Timepoint
0-30 second-6hours
Method of measurement
scale vas
Secondary outcomes
1
Description
reduce use of opioids
Timepoint
6 hours past surgeries
Method of measurement
record to nursing report
Intervention groups
1
Description
use of tablet ozaepam
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
hospital shahid rajaee
Full name of responsible person
Marzieh Asghary
Street address
Shahid Bahonar Blvd. Qazvin University of Medical Sciences
City
qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3336 0015
Fax
+98 28 3332 4970
Email
medicine@qums.ac.ir
Web page address
http://sm.qums.ac.ir/Portal/Home
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
dr amir pemani
Street address
Qazvin- avenue shahd bahonar University of Medical Sciences
City
Shahid Bahonar Blvd, Qazvin, Iran
Province
Qazvin
Postal code
34197-59811
Email
medicine@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
hospital shahid rajaee
Full name of responsible person
marzieh asghary
Position
msc nursing
Latest degree
Master
Other areas of specialty/work
Street address
hospital shahid rajaee
City
qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 5800
Fax
Email
asghary_marzieh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
hosptial shahid rajaee
Full name of responsible person
dr mahdi yusefi
Position
Orthopedic specialist
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
hosptial shahid rajaee
City
Qazvine
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 5800
Fax
Email
asghary_marzieh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
university medical science qazvin
Full name of responsible person
Marzieh Asghary
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
hospital shahid rajaee
City
Qazvine
Province
Qazvin
Postal code
34197-59811
Phone
00
Fax
Email
asghary_marzieh@yahoo.com
Web page address
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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
The total potential data is shared after the unidentifiable people are shared. The main outcomes of the study are shared
When the data will become available and for how long
6 months after completion
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Use in later studies
Use for medical decisions
From where data/document is obtainable
e-mail:\s hc nvdhtj asghary_marzieh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email in the requester, it will be available in less than a week