UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003562 |
|---|---|
| Receipt number | R000004226 |
| Scientific Title | Efficacy of pediatric postoperative pain managements with IV-PCA [*1] or EPI-PCA [*2] after pectus deformity repair with and without 5HT3 blocker. [*1]Intravenous patient controlled analgesia [*2]Epidural patient controlled analgesia |
| Date of disclosure of the study information | 2010/05/12 |
| Last modified on | 2016/01/13 01:33:11 |
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Basic information
Public title
Efficacy of pediatric postoperative pain managements with IV-PCA [*1] or EPI-PCA [*2] after pectus deformity repair with and without 5HT3 blocker.
[*1]Intravenous patient controlled analgesia
[*2]Epidural patient controlled analgesia
Acronym
Efficacy of pediatric postoperative pain managements with IV-PCA or EPI-PCA after pectus deformity repair with and without 5HT3 blocker.
Scientific Title
Efficacy of pediatric postoperative pain managements with IV-PCA [*1] or EPI-PCA [*2] after pectus deformity repair with and without 5HT3 blocker.
[*1]Intravenous patient controlled analgesia
[*2]Epidural patient controlled analgesia
Scientific Title:Acronym
Efficacy of pediatric postoperative pain managements with IV-PCA or EPI-PCA after pectus deformity repair with and without 5HT3 blocker.
Region
| Japan |
Condition
Condition
Pectus deformity
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Minimally invasive surgery has been developed in pediatric pectus deformation repair, however we still have difficulties in postoperative pain management after pectus deformity repair. We investigate that effects of 5HT3 blocker and intend to efficacy of pain managements with IV-PCA or EPI-PCA in children.Currently the sixty percent of female patients suffer from nausea and vomiting with narcotic analgesia. In order to prevent this unfavorable side effects, we administer 5HT3 blocker intravenously, investigate whether it prevents adverse reaction. In this research, we expect to improve quality of postoperative pediatric pain management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
present of nausea and vomiting, unpleasant score,the amount of anesthesia, answer of patient's parents, period of hospitalization
Key secondary outcomes
Aged, agent, height, body weight, anesthesia period, anesthesia method, part of epidural catheter,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
No use of 5HT3 blocker
Interventions/Control_2
Use of 5HT3 blocker
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Female
Key inclusion criteria
1 From 5 to 15 years old girls
2 Schaduled Nuss operation
3 Use of IVPCA or EPIPCA
Key exclusion criteria
1 Mental retardation
2 Hepatic insufficiency, renal insufficiency, cardiac disease,
3 Rejection of parental authority
4 After we explain sufficiently,patient and their parent have negative issue.
5 In case of epidural anesthesia, there is dysspondylism, inflammation of centesis
6 Aberration of coagulant,preoperative anticoagulant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ozaki |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
8-1 Kawadachou Shinjyuku-ku Tokyo Japan
TEL
0333538111
mozaki@anes.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukako Abukawa |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
8-1 Kawadachou Shinjyuku-ku Tokyo Japan
TEL
0333538111
Homepage URL
yukako1@rg8.so-net.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Department of Anesthesiology and Critical Care
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 02 | Day |
Last modified on
| 2016 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004226
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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