UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011463 |
|---|---|
| Receipt number | R000013402 |
| Scientific Title | Comparison of topical anesthetics to relieve venipuncture pain: a randomized controlled trial. |
| Date of disclosure of the study information | 2013/08/12 |
| Last modified on | 2019/04/30 03:40:21 |
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Basic information
Public title
Comparison of topical anesthetics to relieve venipuncture pain: a randomized controlled trial.
Acronym
Comparison of topical anesthetics to relieve venipuncture pain: a randomized controlled trial.
Scientific Title
Comparison of topical anesthetics to relieve venipuncture pain: a randomized controlled trial.
Scientific Title:Acronym
Comparison of topical anesthetics to relieve venipuncture pain: a randomized controlled trial.
Region
| Japan |
Condition
Condition
Healthy adults
Healthy children
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between lidocaine-prilocaine cream and high-dose lidocaine cream to relieve venipuncture pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of visual analog scale
Key secondary outcomes
1. Duration time for blood sampling
2. Site of blood sampling
3. Persons who take blood samples
4. Dose of blood samples
5. Times of venipuncture
6. Side effects
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. lidocaine-prilocaine cream (Right Arm)
2. high-dose lidocaine cream (Left Arm)
Interventions/Control_2
1. high-dose lidocaine cream (Left Arm)
2. lidocaine-prilocaine cream (Right Arm)
Interventions/Control_3
1. high-dose lidocaine cream (Right Arm)
2. lidocaine-prilocaine cream (Left Arm)
Interventions/Control_4
1. lidocaine-prilocaine cream (Left Arm)
2. high-dose lidocaine cream (Right Arm)
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Staff of National Center for Child Health and Development
2) Volunteers who are provided informed, written consent for participation in Japanese
Key exclusion criteria
1. Volunteers who have hypersensitivity to anesthetic agents
2. Volunteers who have skin diseases (erosion or eczema) on the upper arms and/or hands
3. Volunteers who have a experience of blood exam using lidocaine-prilocaine cream or high-dose lidocaine cream
4. Volunteers who judges that the physician is inappropriate
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Ohya |
Organization
National Center for Child Health and Development
Division name
Division of Allergy
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
ohya-y@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Michihata |
Organization
National Center for Child Health and Development
Division name
Department of Postgraduate Education and Training
Zip code
157-8535
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL
03-3416-0181
Homepage URL
michihata-tky@umin.org
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Environment and Children's Study, Ministry of the Environment Government of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
2-10-1 Okura, Setagaya-ku, Tokyo, Japan
Tel
03-3416-0181
seiiku-chiken@ncchd.go.jp
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
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
http://bit.ly/crossoverEMLA
Publication of results
Published
Result
URL related to results and publications
http://bit.ly/crossoverEMLA
Number of participants that the trial has enrolled
24
Results
There was no significant difference between EMLA cream and LMX5 cream (difference 2.83; 95% confidence interval -11.25 to 16.92; P value 0.693).
Compared with 65 minutes or less of coating time of the local anesthetic, the time of more than 65 minutes significantly reduced the VAS scores (difference -22.4, 95% confidence interval -39.5 to -5.34, P value 0.010).
Results date posted
| 2019 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age was 36.7 years (range 25 to 29 years) and males were 33%.
There were no statistically significant differences of background characteristics among the four groups.
Participant flow
One participant was initially assigned to group 4, but when the cream was applied, the participant was mistaken regarding left and right. Due to the nature of this trial, the as-treated analysis was deemed to be more appropriate than the intention-to-treat analysis, and the participant was reassigned to group 1.
Adverse events
Regarding side effects, only one participant complained of mild itching at the application area of EMLA cream. Others did not have skin erythema or any serious side effects.
Outcome measures
There were no significant differences in primary and secondary outcomes between EMLA cream and LMX5 cream.
Plan to share IPD
none
IPD sharing Plan description
Not applicable
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 13 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 13 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 13 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 20 | Day |
Other
Other related information
At the time of submission of a paper about this research, a review request was made, and some protocols were corrected (the coating time of the local anesthetics was added as secondary outcomes).
Management information
Registered date
| 2013 | Year | 08 | Month | 12 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013402
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