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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000027885
Receipt No. 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

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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
Email 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
Email k-2210@kanazawa-mad.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
Email

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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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