UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031893