UMIN-CTR Clinical Trial

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
Email	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
Email	hani_taman@yahoo.com

Sponsor
Institute	Faculty of Medicine, Mansoura University
Institute
Department

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
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 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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050974