UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011463
Receipt No. 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 (Ver. 8)

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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
Last 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
Email ohya-y@ncchd.go.jp

Public contact
1st 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
Email michihata-tky@umin.org

Sponsor
Institute National Center for Child Health and Development
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013402