UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043810 |
|---|---|
| Receipt number | 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 | 2021/09/05 18:55:06 |
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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 ten ml normal saline (IV)
Interventions/Control_2
received caudal analgesia with bupivacaine 0.125% 1 ml/kg + 0.1 mg/kg dexamethasone and ten ml normal saline (IV)
Interventions/Control_3
caudal analgesia with 0.125% bupivacaine 1ml/kg and dexamethasone 0.1 mg/ kg in ten ml normal saline(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, 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
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
m.amr274@yahoo.com
Sponsor or person
Institute
Minia University, Faculty of medicine
anesthesia and intensive care department
Institute
Department
Personal name
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
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 promotes the analgesic effect of caudal bupivacaine either if combined with bupivacaine caudally or via (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 including demographic data, ASA classification, type of surgery, and the duration of the surgery
Participant flow
The first analgesic request was significantly prolonged in the caudal dexamethasone group
Adverse events
ide effects reported in the study were PONV, respiratory depression, and shivering. All side effects were comparable in the three groups except nausea and vomiting were significantly fewer in Group IV
Outcome measures
CHIPPS in the postoperative period was comparable between the 3 study groups at the first and third hours, 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
| 2021 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050008
