UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044626 |
|---|---|
| Receipt number | R000050974 |
| Scientific Title | The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/06/23 04:55:52 |
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Basic information
Public title
The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery
Acronym
The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study
Scientific Title
The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study
Scientific Title:Acronym
The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study
Region
| Africa |
Condition
Condition
efficacy of intravenous ibuprofen on postoperative pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the effect of intravenous ibuprofen on postoperative analgesia after pediatric cardiac surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
measure of this randomized study is the total dose of fentanyl requirements in the first postoperative 24 hours
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravenous ibuprofen
Interventions/Control_2
placebo
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
| 2 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient submitted for on pump elective repair of congenital simple left to right intra cardiac shunt via median sternotomy
Key exclusion criteria
case of refusal of their guardians
redo cardiac surgery
hypersensitivity to ibuprofen
coagulation disorders
renal, hepatic or pulmonary disease
heart failure and moderate to severe pulmonary hypertension.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ibrahim |
| Middle name | Ibrahim |
| Last name | Abd Elbaser |
Organization
Faculty of Medicine, Mansoura University
Division name
ANAETHETSIA AND INTENSIVE CARE DEPARTMENT
Zip code
53333
Address
12 saad zaghloul street
TEL
+447534268934
ibrahimbaser@yahoo.com
Public contact
Name of contact person
| 1st name | HANI |
| Middle name | |
| Last name | TAMAN |
Organization
MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, EGYPT
Division name
ANAETHETSIA AND INTENSIVE CARE DEPARTMENT
Zip code
CF470JF
Address
2 CLOS PWLL GLO
TEL
+447534268934
Homepage URL
hani_taman@yahoo.com
Sponsor or person
Institute
Faculty of Medicine, Mansoura University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Mansoura University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
United Kingdom
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MEDICAL RESEARCH ETHICS COMMITTEE, INSTITUTIONAL REVIEW BOARD, MANSOURA UNIVERSITY
Address
12 saad zaghloul street
Tel
+201092127930
IRB.MFM@hotmail.com
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
| 2021 | Year | 08 | Month | 01 | 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
80
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
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050974
