UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000033314
Receipt number R000037975
Scientific Title 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 2023/01/10 11:47:37

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Basic information

Public title

Study on the effect of tranexamic acid on postoperative pain in tonsillectomy

Acronym

TRAT study

Scientific Title

Study on the effect of tranexamic acid on postoperative pain in tonsillectomy

Scientific Title:Acronym

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

1st name Atsushi
Middle name
Last name Shinto

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Anesthesiology

Zip code

1838561

Address

2-8-29 Musashidai, Fuchu-shi, Tokyo

TEL

042-300-5111

Email

shintoaerrrr@gmail.com


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Shinto

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Anesthesiology

Zip code

1838561

Address

2-8-29 Musashidai, Fuchu-shi, Tokyo

TEL

042-300-5111

Homepage URL


Email

shintoaerrrr@gmail.com


Sponsor or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Tokyo Metropolitan Children's Medical Center Ethics Committee

Address

2-8-29 Musashidai, Fuchu-shi, Tokyo

Tel

042-300-5111

Email

sn_crsc03@tmhp.jp


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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 04 Month 27 Day

Date of IRB

2018 Year 04 Month 27 Day

Anticipated trial start date

2018 Year 06 Month 08 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 07 Month 06 Day

Last modified on

2023 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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