UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study of EMLA cream and lidocaine tape on the reduction of the pain at venipunture
Acronym	Comparative study of EMLA cream and lidocaine tape
Scientific Title	Comparative study of EMLA cream and lidocaine tape on the reduction of the pain at venipunture
Scientific Title:Acronym	Comparative study of EMLA cream and lidocaine tape
Region	Japan

Condition
Condition	Patients who receive general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of EMLA cream and lidocaine tape on the reduction of the pain at venipunture.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual Analogue Scale(VAS)
Key secondary outcomes	Verbal Rating Scale(VRS), adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
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 and lidocaine tape are applied at dorsum of left and right hand, respectively. These local anesthetics application are according to manufacturers' instruments.
Interventions/Control_2	EMLA cream and lidocaine tape are applied at dorsum of right and left hand, respectively. These local anesthetics application are according to manufacturers' instruments.
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who is planned to receive general anesthesia. ASA-PS(American Society of Anesthesiologists Physical Status)1-3.
Key exclusion criteria	Past history of allergy for local anesthetics. Past history of contact dermatitis. Dermal abnormality on the puncture sites. Severe hepatic, renal or cardiovascular disease. Methemogulobinemia Porphyria Pregnancy or lactation period Communication difficulty Sensory disturbance Anesthesiologist or attending physician determine that the patient is inappropriate for this study.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomomi Matsumoto
Organization	Tomakomai city hospital
Division name	Anesthesiology
Zip code
Address	1-5-20 Shimizu-cho, Tomakomai, Hokkaido
TEL	0144-33-3131
Email	tmrn000@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Tomomi Matsumoto
Organization	Tomakomai city hospital
Division name	Anesthesiology
Zip code
Address	1-5-20 Shimizu-cho, Tomakomai, Hokkaido
TEL	0144-33-3131
Homepage URL
Email	tmrn000@gmail.com

Sponsor
Institute	Tomakomai city hospital
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Other
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	2016 Year 07 Month 05 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	2016 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date	2016 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	For analgesia of venipuncture procedures, either EMLA cream before 60 minutes of procedure, or Lidocaine tape before 30 minutes of procedure is used. In this study, because each patient needs two venous root for surgery, both EMLA cream and Lidocaine tape are used in every patient simaltaneously. Same patient was asked the pain after venipuncture.

Management information
Registered date	2016 Year 07 Month 05 Day
Last modified on	2018 Year 09 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026462

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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