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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020407
Receipt No. R000023570
Scientific Title Nebulized fentanyl is it effective in pediatric post-operative analgesia?
Date of disclosure of the study information 2016/01/03
Last modified on 2015/12/31

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Basic information
Public title Nebulized fentanyl is it effective in pediatric post-operative analgesia?
Acronym Nebulized fentanyl is it effective in pediatric post-operative analgesia?
Scientific Title Nebulized fentanyl is it effective in pediatric post-operative analgesia?
Scientific Title:Acronym Nebulized fentanyl is it effective in pediatric post-operative analgesia?
Region
Africa

Condition
Condition this clinical trial is in editing and data has been collected
Classification by specialty
Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary goal of this study was to compare analgesic, sedative and side effects of nebulized fentanyl with standard IV fentanyl dose for postoperative pain relief in pediatric patients having lower abdominal surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Phase IV

Assessment
Primary outcomes Patients were assessed for pain by FLACC score
Key secondary outcomes sedation by Ramsay sedation scale (RSS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 IV dose of fentanyl was given as 1mg/kg in IV solution for group IV and nil in nebulization solution for group N.
Interventions/Control_2 fentanyl was given as 2mg/kg in nebulized solution for N and nil in IV solution for group IV.
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
6 years-old >=
Gender Male and Female
Key inclusion criteria Patients of either gender between 3 and 6 years of age scheduled for lower abdominal surgery under general anesthesia
Key exclusion criteria Patients with active respiratory tract infection, congenital anomalies, congenital cardiac, hepatic and renal insufficiency, coagulation disorders or hypersensitivity to opioids
Target sample size 17

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hani I. Taman
Organization Mansoura faculty of medicine, Mansoura University
Division name Mansoura University Children Hospital,
Zip code
Address 10 gehan street, mansoura egypt
TEL +81-201008288242
Email hani_taman@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Hani I. Taman
Organization Mansoura faculty of medicine, Mansoura University
Division name Mansoura University Children Hospital
Zip code
Address 10 gehan street, mansoura egypt
TEL +81-201008288242
Homepage URL
Email hani_taman@yahoo.com

Sponsor
Institute Mansoura faculty of medicine
Institute
Department

Funding Source
Organization self funding
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
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
2016 Year 01 Month 03 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
2013 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2013 Year 12 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
2015 Year 12 Month 31 Day
Last modified on
2015 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023570

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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