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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000023030 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Patients who receive general anesthesia | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 24 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |