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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033314
Receipt No. R000037975
Official scientific title of the study Study on the effect of tranexamic acid on postoperative pain in tonsillectomy
Date of disclosure of the study information 2018/07/07
Last modified on 2018/07/06

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Basic information
Official scientific title of the study Study on the effect of tranexamic acid on postoperative pain in tonsillectomy
Title of the study (Brief title) TRAT study
Region
Japan

Condition
Condition
Sleep apnea syndrome
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1
Tranexamic acid is used to relieve sore throat caused by tonsillectomy and prevent postoperative bleeding. This study is to investigate the superiority of tranexamic acid as an analgesic adjuvant for tonsillectomy and postoperative pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes
Number of times of use of the analgesic agent temporarily used on the day of surgery and by 24:00 the next day
Key secondary outcomes The amount of bleeding, the presence or absence of hemostasis treatment after the end of surgery, the presence and absence and frequency of postoperative nausea and vomiting, the day of surgery on the day of dinner and surgery, the percentage of patients who were able to eat 50% or more of food intake of breakfast, the degree of pain due to age Difference, preoperative McGill Oximetry Score, correlation between DT 95 and airway securing situation during introduction extubation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tranexamic acid
During surgery and the next day after surgery before breakfast.2 times administration in total.
15 mg/kg(0.3 ml/kg)
30 mg/kg(0.6 ml/kg) in total.
Interventions/Control_2 Saline
Same as above.
0.3 ml/kg
0.6 ml/kg in total.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
3 years-old <=
Age-upper limit
9 years-old >=
Gender Male and Female
Key inclusion criteria Patients aged 3 to 10
tonsillectomy with palatal tonsillectomy, palatine tonsillectomy + adenoidectomy, palatine tonsillectomy + tympanic tubing, palatine tonsillectomy + adenoidectomy + tympanic tubing, palatine tonsillectomy + nasal cavity mucosal ablation, palatine tonsillectomy + Patients undergoing either adenoidectomy + nasal mucosal ablation, palatine tonsillectomy + tympanic tubing + nasal cavity mucosal ablation, palatine tonsillectomy + adenoidectomy + nasal mucosal ablation
patient with ASA classification 1 or 2
Patient who got written informed consent from the substitute
Key exclusion criteria Patients who are allergic to the drugs used in the protocol.
Patient using anticoagulant.
Patient using thrombin.
Patient planned to enter ICU after surgery
patient with tube feeding
palatine tonsillectomy for tonsillar abscess
Patient in emergency operation
Patient who is difficult to evaluate by the scale factor
When judging that the doctor in charge is inappropriate
Target sample size 254

Research contact person
Name of lead principal investigator Atsushi Shinto
Organization Tokyo Metropolitan Children's Medical Center
Division name Anesthesiology
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-300-5111
Email shintoaerrrr@gmail.com

Public contact
Name of contact person Atsushi Shinto
Organization Tokyo Metropolitan Children's Medical Center
Division name Anesthesiology
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-300-5111
Homepage URL
Email shintoaerrrr@gmail.com

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Children's Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 04 Month 27 Day
Anticipated trial start date
2018 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 06 Day
Last modified on
2018 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037975

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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