UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000037975
