UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020407 |
|---|---|
| Receipt number | 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 06:13:51 |
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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
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
hani_taman@yahoo.com
Sponsor or person
Institute
Mansoura faculty of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023570
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| Registered date | File name |
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| Registered date | File name |
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