UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027885 |
|---|---|
| Receipt number | R000031893 |
| Scientific Title | Comparative study of EMLA cream and lidocaine tape on the reduction of the pain at arteriovenous fistula puncture in hemodialysis patients: A multicentre study. |
| Date of disclosure of the study information | 2017/06/23 |
| Last modified on | 2020/03/27 13:42:15 |
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Basic information
Public title
Comparative study of EMLA cream and lidocaine tape on the reduction of the pain at arteriovenous fistula puncture in hemodialysis patients: A multicentre study.
Acronym
Study of the painless effect at arteriovenous fistula puncture
Scientific Title
Comparative study of EMLA cream and lidocaine tape on the reduction of the pain at arteriovenous fistula puncture in hemodialysis patients: A multicentre study.
Scientific Title:Acronym
Study of the painless effect at arteriovenous fistula puncture
Region
| Japan |
Condition
Condition
End-stage renal disease requiring maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of EMLA cream and lidocaine tape on the reduction of the pain at arteriovenous fistula puncture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Painless using Visual Analogue Scale (VAS)
Key secondary outcomes
Health-related quality of life using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EMLA CREAM
Interventions/Control_2
Youpatch tape
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving maintenance hemodialysis
Key exclusion criteria
1. Past history of allergy for local anesthetics.
2. Past history of contact dermatitis for ointment
3. Severe hepatic disease
4. Methemogulobinemia
5. Porphyria
6. Pregnancy or lactation period
7. Dermal abnormality on the puncture site
8. Severe sensory disturbance in the limbs
9. Visual disturbance or hearing impairments
10. Patients with troubles when receiving vascular punctures over the last three hemodialysis treatments
11. Patients who are unable to communicate adequately with observers due to conditions such as consciousness disorder
12. Patients whom responsible doctors consider as inappropriate participants
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Fujimoto |
Organization
Kanazawa Medical University
Division name
Nephrology
Zip code
Address
1-1 Daigaku Uchinada Kahoku District Ishikawa Japan
TEL
076-286-2211
k-2210@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiji Fujimoto |
Organization
Kanazawa Medical University
Division name
Nephrology
Zip code
Address
1-1 Daigaku Uchinada Kahoku District Ishikawa Japan
TEL
076-286-2211
Homepage URL
k-2210@kanazawa-mad.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 23 | 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
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2020 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031893
| 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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| Registered date | File name |
