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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043810
Receipt No. R000050008
Scientific Title Comparison between low dose intravenous and caudal dexamethasone as adjuvants to caudal bupivacaine in children undergoing lower abdominal surgeries
Date of disclosure of the study information 2021/05/01
Last modified on 2021/04/01

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Basic information
Public title low dose intravenous and caudal dexamethasone in caudal anesthesia
Acronym low dose intravenous and caudal dexamethasone
Scientific Title Comparison between low dose intravenous and caudal dexamethasone as adjuvants to caudal bupivacaine in children undergoing lower abdominal surgeries
Scientific Title:Acronym Comparison between low dose intravenous and caudal dexamethasone as adjuvants to caudal bupivacaine in children undergoing lower abdominal surgeries: low dose intravenous and caudal dexamethasone
Region
Africa

Condition
Condition prospective study
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 efficacy of low dose dexamethasone intravenous and as adjuvant in caudal anesthesia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes the duration of the postoperative caudal analgesia and severity of postoperative pain
Key secondary outcomes Number of rescue analgesic doses, residual motor block, and side effects like nausea and vomiting

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 received caudal analgesia with 0.125% bupivacaine 1ml/kg and 10ml normal saline intravenous (IV)
Interventions/Control_2 received caudal analgesia with bupivacaine 0.125% 1 ml/kg + 0.1 mg/kg dexamethasone and 10ml normal saline intravenous (IV)
Interventions/Control_3 caudal analgesia with 0.125% bupivacaine 1ml/kg and dexamethasone 0.1 mg/ kg in 10ml normal saline intravenous (IV)
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
5 years-old >
Gender Male and Female
Key inclusion criteria ASA I, II
Key exclusion criteria coagulopathies, congenital spinal deformities, infection at the block targeted site, or with known allergy to any of the drugs included in the study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Amr
Middle name Nady
Last name abdelrazik
Organization Minia University, Faculty of medicine
Division name anesthesia and intensive care department
Zip code 61768
Address Minya Elgedida
TEL 00201023451177
Email m.amr274@yahoo.com

Public contact
Name of contact person
1st name Amr
Middle name Nady
Last name abdelrazik
Organization Minya University, Faculty of medicine
Division name anesthesia and intensive care department
Zip code 61768
Address Minya Elgedida
TEL 00201023451177
Homepage URL
Email m.amr274@yahoo.com

Sponsor
Institute Minia University, Faculty of medicine
anesthesia and intensive care department
Institute
Department

Funding Source
Organization Minia University, Faculty of medicine
anesthesia and intensive care department
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Egyptian

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Minya University
Address Minya Elgedida
Tel 00862366100
Email sara.mohamed@mu.edu.eg

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 Minia University, Faculty of medicine
anesthesia and intensive care department

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 01 Day

Related information
URL releasing protocol http://www.editorialmanager.com:10161/pcorm/,
Publication of results Unpublished

Result
URL related to results and publications http://www.editorialmanager.com:10161/pcorm/,
Number of participants that the trial has enrolled 150
Results Dexamethasone enhances the analgesic effect of caudal bupivacaine either if combined with bupivacaine caudally or via intravenous (iv) route compared to the control group.
Results date posted
2021 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics There were no statistically significant differences between the study groups as regards demographic data, ASA classification, body weight, type of surgery, and the duration of the surgery
Participant flow Time to first analgesic request was significantly longer in the caudal dexamethasone group
Adverse events ide effects reported in the study were nausea and vomiting, respiratory depression, and shivering. All side effects incidence was comparable in the three groups except nausea and vomiting were significantly fewer in Group IV
Outcome measures CHIPPS scores in the postoperative period were comparable between the three study groups at the first and third hour, after 6 hours both dexamethasone groups showed lower scores, group D showed significantly lower scores at 24 hours
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2020 Year 05 Month 01 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 01 Month 01 Day
Date of closure to data entry
2021 Year 01 Month 01 Day
Date trial data considered complete
2021 Year 07 Month 01 Day
Date analysis concluded
2021 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2021 Year 04 Month 01 Day
Last modified on
2021 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050008

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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