UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023030
Receipt number R000026462
Scientific Title Comparative study of EMLA cream and lidocaine tape on the reduction of the pain at venipunture
Date of disclosure of the study information 2016/07/05
Last modified on 2018/09/13 08:22:02

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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 or person

Institute

Tomakomai city hospital

Institute

Department

Personal name



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

Value
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