UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029254 |
|---|---|
| Receipt number | 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 | 2021/03/29 15:45:55 |
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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 | Hiroshi |
| Middle name | |
| Last name | Hataya |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2-8-29 Mushashidai, Fuchu-city, Tokyo, Japan
TEL
042-300-5111
hiroshi_hataya@tmhp.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Matumura |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Department of General Pediatrics
Zip code
183-8561
Address
2-8-29 Mushashidai, Fuchu-city, Tokyo, Japan
TEL
042-300-5111
Homepage URL
osamupineville@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Mushashidai, Fuchu-city, Tokyo, Japan
Tel
042-300-5111
osamupineville@gmail.com
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
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
520
Results
383 patients used topical anesthesia while 96 patients didn't. The success rate of first intravenous catheterization insertion was 77.3% in the topical anesthesia group while placebo group's success rate was 67.7%.
The underlying disease, years of experience, the use of LED transilluminator, and the presence of hand motion was adjusted in the comparison analysis. The comparison analysis showed OR 2.0 (95%CI 1.1-3.7) in the topical anesthesia group compared to placebo group.
Results date posted
| 2021 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 21 | Day |
Baseline Characteristics
All patients who are less than 16 years old in need of intravenous catheterization.
Patients who are
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.
4. Patients who are allergic to lidocaine (topical anesthesia),
5. Patients who are difficult to use topical anesthesia due to skin condition were excluded.
were excluded.
Participant flow
Patients who came to the ER from 9:00-17:00 Monday through Friday and in need of intravenous catheterization were asked for topical anesthesia use procedure before catheterization. The success rate of 1st attempt intravenous catheterization were analyzed.
Adverse events
One patient's topical anesthesia were accidently put on the clothes instead of the skin.
Outcome measures
The success rate of intravenous catheterization
Plan to share IPD
None
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 14 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 27 | Day |
Other
Other related information
None to be noted
Management information
Registered date
| 2017 | Year | 09 | Month | 22 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031781
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/03/29 | 研究実施計画書_編集履歴削除版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
