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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029254
Receipt No. R000031781
Scientific Title Peripheral Intravenous Cannulation Outcome with the use of topical anaesthesia in pediatric emergency department in Japan: A prospective observational study
Date of disclosure of the study information 2017/09/22
Last modified on 2017/10/03

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Basic information
Public title Peripheral Intravenous Cannulation Outcome with the use of topical anaesthesia in pediatric emergency department in Japan: A prospective observational study
Acronym PICO Study
Scientific Title Peripheral Intravenous Cannulation Outcome with the use of topical anaesthesia in pediatric emergency department in Japan: A prospective observational study
Scientific Title:Acronym PICO Study
Region
Japan

Condition
Condition Healthy Children who presented in the ED
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the success rate of peripheral intravenous insertion with the use of lidocaine patch.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The success rate of peripheral intravenous insertion with the use of lidocaine patch.
Key secondary outcomes 1 Success rate between peripheral intravenous insertion with lidocaine patch and without lidocaine patch in the previous trial (UMIN000014730)
2 Duration of lidocaine patch attachment and success rate
3 The pain scale and success rate
4 The pain scale with/without lidocaine patch
5 The pain scale and duration of lidocaine patch attachment
6 Success rate and person's experience as a pediatrician

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients who visited the ED from 9 AM to 5 PM through Monday to Friday (National holiday excluded).
2. Patients who are less than 16 years old.
3. Patients Who's intravenous access is warranted and senior residents attempted the initial procedure.
Key exclusion criteria 1. Evaluated as "blue triage" based on JTAS triage system or similar conditions at the initial encounter.
(unstable breathing or circulation in need of emergent intervention)
2. The doctor in charge of the study or the doctors in alliance with the study decide ineligible to participate in the study.
3. Patients or the guardians who were unwilling to participate in the study.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Hataya
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of General Pediatrics
Zip code
Address 2-8-29 Mushashidai, Fuchu-city, Tokyo, Japan
TEL 042-300-5111
Email hiroshi_hataya@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Matumura
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of General Pediatrics
Zip code
Address 2-8-29 Mushashidai, Fuchu-city, Tokyo, Japan
TEL 042-300-5111
Homepage URL
Email osamu_matsumura@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

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 東京都立小児総合医療センター
Tokyo Metropolitan Children’s Medical Center

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 22 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 02 Day
Last follow-up date
2018 Year 10 Month 01 Day
Date of closure to data entry
2018 Year 10 Month 01 Day
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information None to be noted

Management information
Registered date
2017 Year 09 Month 22 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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