Evaluation of the effectiveness of oral Tizanidine in the severity of pain after septoplasty
Design
Double blind randomized controlled trial. People doing postoperative care and outcome (severity of pain) assessment, were blinded. Sample size was 70. Participant were selected by convenience sampling and were later allocated to two groups randomly.
Settings and conduct
This study will be conducted in Shafa Kerman hospital on 70 eligible patients in ENT who are candidates for septoplasty surgery. The surgeon and the anesthetist and the pain assessor resident will be blind to the prescription.
35 patients per arm were calculated and the total sample size was 70 patients.
Patients will be randomly divided into two groups by using the random numbers table. This study was first approved by the Ethics Committee of Kerman University of Medical Sciences as the approved proposal, and then a written consent form will be obtained from all patients participating in the post-briefing study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18 to 50 years of age in stage 1 and 2 of ASA Exclusion Criteria: 1-Stomach ulcer
2- Use of immune suppressants and corticosteroids
3- Contraindications to Tizanidine
4- Cases that need to be treated by different anesthesia or surgery methods
5- Drug addict patients
6- Certain patients such as kidney failure or liver failure
7- Patients with ASA 3
Intervention groups
Intervention: Tizanidine 4 mg , 2 hours before surgery
Control: Vitamin B1 tablets 100 mg, 2 hours before surgery
Main outcome variables
The severity of post-surgery pain by pain Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190921044831N1
Registration date:2019-12-27, 1398/10/06
Registration timing:retrospective
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
Farima Minaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 4320
Email address
minaee.farima@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-04-09, 1393/01/20
Expected recruitment end date
2015-03-11, 1393/12/20
Actual recruitment start date
2014-04-09, 1393/01/20
Actual recruitment end date
2015-03-11, 1393/12/20
Trial completion date
2015-03-11, 1393/12/20
Scientific title
Comparison of the effectiveness of oral Tizanidine in severity of pain after Septoplasty, in two groups of drug and placebo
Public title
"Effect of Tizanidine in reducing the pain of after septoplasty"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with septoplasty class 1 or/and 2 ASA
Not history of gastric ulcer
Not history of using corticosteroids or other immune system suppressors
Exclusion criteria:
Allergy to Tizanidine
Age < 18 y or >50 y
Re-Septoplasty
Sinorhinoplasty
Contraindication of Tizanidine therapy
Cases that need to be treated differently by anesthesia or surgery
Addiction
Hepatic or renal disorder
Cases of ASA 3
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
71
Actual sample size reached:
71
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization by Randomised number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Surgeons and physicians who were assessing pain severity and anesthesia survivors and also patients were blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences Ethics committee
Street address
Haft Bagh Alavi Highway
City
Kerman
Province
Kerman
Postal code
76169-13555
Approval date
2009-09-06, 1388/06/15
Ethics committee reference number
IR.KMU.REC.1388.236
Health conditions studied
1
Description of health condition studied
Deviation of nasal septum
ICD-10 code
J34.2
ICD-10 code description
Deflection or deviation of septum (nasal)(acquired)
Primary outcomes
1
Description
Pain of after septoplasty surgery
Timepoint
After 4, 8 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral Tizanidine tablet 4 mg (Hakim Pharmacy Company) 2 hours before surgery
Category
Treatment - Drugs
2
Description
Control group: Placebo, Oral Vitamin B1 100 mg tablet (Poursina Pharmacy Company) 2 hours before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Kerman hospital
Full name of responsible person
Aliasghar Arabi
Street address
Ear, Throat and Nose & Head and Neck Surgery Department, Shafa hospital, Kerman University of Medical Science, Kosar Blvd, Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
a_arabi@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/sh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermen Medical University, Chancel of research
Full name of responsible person
Ali asghar Arabi Mianroodi
Street address
Ear, Throat and Nose & Head and Neck Surgery Department, Shafa hospital, Kerman University of Medical Science, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
a_arabi@kmu.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermen Medical University, Chancel of research
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
Kerman University of Medical Sciences
Full name of responsible person
علی اصغر عربی
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3132 5856
Email
a_arabi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
َAliasghar Arabi Mianroodi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3132 5856
Email
a_arabi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
َAliasghar Arabi Mianroodi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3132 5856
Email
a_arabi@kmu.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of this clinical trial will be sent to the authored journals for publication and after publication, if any researchers who wish to cite this article requests, the coded information without any participants' personal information; will be sent.
When the data will become available and for how long
start of accessibility will be 3 months after publication
To whom data/document is available
محققینی که به طور معتبر قصد ارجاع به مقاله را دارند.
Under which criteria data/document could be used
The results and preliminary data collected are confidential and coded by researchers who intend to refer to this article.
From where data/document is obtainable
Formally request the corresponding author of the article.
What processes are involved for a request to access data/document
The applicant firstly proves his credibility as a researcher by introducing himself and his ORCID code, and then formally communicate with the corresponding author of the paper, explaining the title of his research and the purpose of obtaining this article's information and makes his request. After consulting with other authors, the author in charge of providing the researcher's request should be sure of the confidentiality of the data is maintained.