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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043033
Receipt No. 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

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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
Email 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
Email hani_taman@yahoo.com

Sponsor
Institute MANSOURA FACULTY OF MEDICINE, MANSOURA UNIVERSITY, MANSOURA, EGYPT
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049125

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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