UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043033 |
|---|---|
| Receipt number | R000049125 |
| 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 | 2021/06/30 |
| Last modified on | 2021/01/16 23:46:51 |
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Basic information
Public title
The effect of intravenous ibuprofen on postoperative pain and opioid consumption after pediatric cardiac surgery: A randomized, double-blind, controlled study
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
PROTOCOL APPLICATION AND ACCEPTANCE BY IRB
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
Others
Basic objectives -Others
measures are postoperative pain score in the first postoperative 24 hours, time to eExtubation, postoperative renal function test and postoperative non-surgical complications.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of IV ibuprofen on pain management in children during the first 24 hours after surgery.
Key secondary outcomes
measure the effect of IV ibuprofen on renal function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
to evaluate the effect of intravenous ibuprofen on postoperative analgesia after pediatric cardiac surgery for first 24 hours after surgery
Interventions/Control_2
to assess VAS score in children
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
children of either sex with their age ranging from 2 to 12 years submitted for on pump elective repair of congenital simple left to right intra cardiac shunt via median sternotomy.
Key exclusion criteria
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 | HANI |
| Middle name | |
| Last name | TAMAN |
Organization
MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, EGYPT
Division name
ANAETHETSIA AND INTENSIVE CARE DEPARTMENT
Zip code
53000
Address
12 ELEMAM MOHAMED ABDO
TEL
+447534268934
hani_taman@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
53000
Address
12 ELEMAM MOHAMED ABDO
TEL
+447534268934
Homepage URL
hani_taman@yahoo.com
Sponsor or person
Institute
MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, MANSOURA, EGYPT
Institute
Department
Personal name
Funding Source
Organization
MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, MANSOURA, EGYPT
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
MEDICAL RESEARCH ETHICS COMMITTEE, INSTITUTIONAL REVIEW BOARD, MANSOURA UNIVERSITY
Address
14 ELGOMHORIA STREET, MANSOURA, EGYPT
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 | 06 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 20 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049125
| Research Plan | |
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| 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 |
