UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010623 |
|---|---|
| Receipt number | R000012422 |
| Scientific Title | evaluation of the sedation effect of intranasal ketamine and midazolam to perform gastric aspirates in children: a randomized, pilot study |
| Date of disclosure of the study information | 2013/10/04 |
| Last modified on | 2013/10/03 17:54:36 |
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Basic information
Public title
evaluation of the sedation effect of intranasal ketamine and midazolam to perform gastric aspirates in children: a randomized, pilot study
Acronym
utility of intranasal ketamine and midazolam to perform gastric aspirates in children: a pilot study
Scientific Title
evaluation of the sedation effect of intranasal ketamine and midazolam to perform gastric aspirates in children: a randomized, pilot study
Scientific Title:Acronym
utility of intranasal ketamine and midazolam to perform gastric aspirates in children: a pilot study
Region
| Europe |
Condition
Condition
children with suspected tuberculosis who need to perform gastric aspirates for microbiological diagnosis
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluation of the sedative effect of intranasal ketamine and midazolam to perform gastric aspirates in childrn
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
evaluation of the sedative effect of intranasal ketamine and midazolam to perform gastric aspirates in childrn
Key secondary outcomes
evaluation of side effects of intranasal ketamine and midazolam to perform gastric aspirates in children: a pilot study
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
- Intervention group: children receive intranasal ketamine (2 mg/kg) and midazolam (0.5 mg/kg) to perform gastric aspirates in children.
- placebo: children receive 1 ml of normal salin solution in each nostril
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
| 1 | years-old | < |
Age-upper limit
| 14 | years-old | > |
Gender
Male and Female
Key inclusion criteria
children with suspected tuberculosis
Key exclusion criteria
known allergy to ketamine or benzodiazepine, ASA classification of III or higher, upper respiratory tract infection with nasal discharge, known liver disease or respiratory distress
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | antonio chiaretti |
Organization
Catholic University - A. Gemelli Hospital, rome, Italy
Division name
Department of Pediatrics
Zip code
Address
L.go A, Gemelli 8, 00168, Rome, Italy
TEL
+81-0390630154348
achiaretti@yahoo.it
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | antonio chiaretti |
Organization
Catholic University - A. Gemelli Hospital, rome, Italy
Division name
Department of Pediatrics
Zip code
Address
L.go A, Gemelli 8, 00168, Rome, Italy
TEL
+81-0390630154348
Homepage URL
achiaretti@yahoo.it
Sponsor or person
Institute
no sponsoro for this study
Institute
Department
Personal name
Funding Source
Organization
no external funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
| 2013 | Year | 10 | Month | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | 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
| 2013 | Year | 04 | Month | 30 | Day |
Last modified on
| 2013 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
