Determining of the effect of tranexamic acid on perioperative bleeding in patients undergoinig adenotonsillectomy
Design
A randomized clinical trial on 160 patients with control group, society based and pragmatic, single blinded
Settings and conduct
After IV line taking, 5ml/kg crystaloid fluid, 0.05mg/kg midazolam and 1µg/kg remifentanil will be injected. the general anesthesia will be inducted by 5mg/kg sodium thiopental and 0.6mg/kg atracurium for intubation faciliation. one group will receive 10ml/Kg tranexamic acid ampule stat before surgery but other group wont receive it. The patients don't know if they receive it or not.
the patients will be moved to ward when the pain be stopped or reduced, and bleeding stopped with no nausea and vomiting. all patients will be survived in hospital for 24h after surgery. The bleeding volume will be evaluated with scaling serum and blood mixture in suction glass. Generally the used serum will be deducted from mixture volume and blood volume will be identified. Data collecting tool is information forms which includes demographics and study variables.
Participants/Inclusion and exclusion criteria
Patient will be selected from tonsilectomy candidates ages 6months to 14years old. We used simple selection according to inclusion and exclusion criteria after urine analysis for hematuria rule out.
Intervention groups
The tonsilectomy indicated patients ages 6 months to 14 years old who were referred to ENT clinic of khatamolanbia hospital of zahedan in 2017
Allergy to tranexamic acid
Hematuria history
Patients disagreement to attend in study
Age
From 6 months old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
160
Actual sample size reached:
160
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly be divided into two groups of 6 blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients dont know if they had received medicine or placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic comittee of Zahedan University of Medical Sciences
Street address
Dr Hesabi Square.Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2017-05-25, 1396/03/04
Ethics committee reference number
ir.zaums.rec.1396.344
Health conditions studied
1
Description of health condition studied
Adenoid
ICD-10 code
J35.2
ICD-10 code description
Hypertrophy of adenoids and Enlargement of adenoids
Primary outcomes
1
Description
The bleeding volume which is evaluated in first 24h after surgery.
Timepoint
First 24h after surgery
Method of measurement
Graduated cylinder
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who received tran examic acid: After IV line taking, 5ml/kg crystaloid fluid, 0.05mg/kg midazolam and 1µg/kg remifentanil will be injected. The general anesthesia will be inducted by 5mg/kg sodium thiopental and 0.6mg/kg atracurium for intubation faciliation. One group will receive 10ml/Kg tranexamic acid ampule stat before surgery.
Category
Treatment - Drugs
2
Description
Control group: Patients who received distilled water as placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT clinic of Khatamolanbia hospital of Zahedan
Full name of responsible person
Behnam Shamsaddin
Street address
Begining of Jamejam Avenue, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
b.shamsaddin@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Gholamali Dashty Khavidki
Street address
Dr Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
b.shamsaddin@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Behnam Shamsadin
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr Hesabi Square, Zahedan University of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Fax
Email
b.shamsaddin@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Behnam Shamsadin
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr Hesabi Square, Zahedan University of Medical Scineces
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Fax
Email
b.shamsaddin@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Behnam Shamsaddin
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr Hesabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
b.shamsaddin@zaums.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
According to ethics rules of Zahedan medical university for patients data privacy
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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