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
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
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
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 | |
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| Registered date | File name |
