UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010623
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email achiaretti@yahoo.it

Sponsor
Institute no sponsoro for this study
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012422

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.