UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013938 |
|---|---|
| Receipt number | R000016250 |
| Scientific Title | Study of analgesic and sedative effects of suppository yokukansan for pediatric patient with postoperative tonsillectomy |
| Date of disclosure of the study information | 2014/05/13 |
| Last modified on | 2015/08/27 16:05:11 |
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Basic information
Public title
Study of analgesic and sedative effects of suppository yokukansan for pediatric patient with postoperative tonsillectomy
Acronym
Study of analgesic and sedative effects of suppository yokukansan for pediatric patient with postoperative tonsillectomy
Scientific Title
Study of analgesic and sedative effects of suppository yokukansan for pediatric patient with postoperative tonsillectomy
Scientific Title:Acronym
Study of analgesic and sedative effects of suppository yokukansan for pediatric patient with postoperative tonsillectomy
Region
| Japan |
Condition
Condition
Pediatric patient with
tonsillectomy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to clarify an analgesic and sedative effect of yokukansan in pediatric patient with postoperative tonsillectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of sedation score 0,6 and 12 hours after leaving from operating room between the two groups.
Sedation score: Behavioral Observational Pain Scale (BOPS) and Children's Hospital Eastern Ontario Pain Scale (CHEOPS)
Key secondary outcomes
Comparison of the Used amount of analgesics between the two groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group T: The subjects in the group T are received yokukansan suppository (0.25g/kg) during operation.
Interventions/Control_2
Group F: The subjects in the group F are injected fentanyl (0.005mg/kg) during operation
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
| 3 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Pediatric patient with tonsillectomy under general anesthesia
b) Patients that a written informed consent was obtained to participate in this study.
Key exclusion criteria
a) Patients who take herbal medicines
b) Patients who are allergic to medicines, or foods related to the test material of this trial
c) Patients who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
d) Patients who are judged not suitable to participate in this trial by physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoko Kawahara |
Organization
Nissay Hospital
Division name
Anesthesiology
Zip code
Address
6-3-8, Itachibori, Nishi-ku, Osaka, 550-0012
TEL
06-6543-3581
kawahara.ryoko@nissay-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoko Kawahara |
Organization
Nissay Hospital
Division name
Anesthesiology
Zip code
Address
6-3-8, Itachibori, Nishi-ku, Osaka, 550-0012
TEL
06-6543-3581
Homepage URL
kawahara.ryoko@nissay-hp.or.jp
Sponsor or person
Institute
Nissay Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | 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
| 2014 | Year | 05 | Month | 12 | Day |
Last modified on
| 2015 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016250
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
