UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017684 |
|---|---|
| Receipt number | R000019321 |
| Scientific Title | Evaluation on pain relief by applying mixed solution with lidocaine, adrenaline, tetracaine (LAT solution) to lacerated wound |
| Date of disclosure of the study information | 2015/05/26 |
| Last modified on | 2016/06/02 22:40:38 |
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Basic information
Public title
Evaluation on pain relief by applying mixed solution with lidocaine, adrenaline, tetracaine (LAT solution) to lacerated wound
Acronym
Evaluation on pain relief from LAT solution
Scientific Title
Evaluation on pain relief by applying mixed solution with lidocaine, adrenaline, tetracaine (LAT solution) to lacerated wound
Scientific Title:Acronym
Evaluation on pain relief from LAT solution
Region
| Japan |
Condition
Condition
lacerated wound
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effectiveness and safety of mixed solution with lidocaine, adrenaline, and tetracaine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Degree of pain relief
Key secondary outcomes
Parental satisfaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Applying mixed solution with lidocaine, adrenaline, and tetracaine
Interventions/Control_2
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
| 8 | years-old | <= |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Needs manipulation of wounds
Requires local anesthetic to control pain
Length of wound is less than 3cm
Key exclusion criteria
contains mucous membrane
history of allergic reactions
contaminated wound
contraindicated to one of agents
unable to assess own pain scale due to cognitive impairment
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuaki Inoue |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Pediatric Emergency Medicine
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-300-5111
nobuaki_inoue@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Inoue |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Pediatric Emergency Medicine
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-300-5111
Homepage URL
nobuaki_inoue@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center, Division of Pediatric Emergency Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
都立小児総合医療センター、Tokyo Metropolitan Children's Medical Center
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 26 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 26 | Day |
Last modified on
| 2016 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019321
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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