Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000957493
Ethics application status
Approved
Date submitted
4/07/2016
Date registered
20/07/2016
Date last updated
20/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of ondansetron on the duration of caudal block with bupivacaine on children who undergoing infraumbilical surgery
Scientific title
Effect of intravenously administered ondansetron on the duration and level of caudal block on pediatric patients whom ondergoing infraumbilical surgery
Secondary ID [1] 289598 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infraumbilical pediatric surgery 299370 0
Condition category
Condition code
Anaesthesiology 299355 299355 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intravenous 0.1 mg/kg ondansetron in 30 seconds will given pediatric patients whom undergo infraumbilical surgery before immediately prior to caudal block. Caudal block will performed regardless of enrolment in this trial.
Intervention code [1] 295207 0
Treatment: Drugs
Comparator / control treatment
Control treatment is intravenous normal saline at the same volume.
Control group
Placebo

Outcomes
Primary outcome [1] 298825 0
caudal block duration time of analgesic effect will measured with faces pain scale
Timepoint [1] 298825 0
postoperative 24 hour (1 time for every hour)
Secondary outcome [1] 325314 0
caudal block sensorial level will tested with pin prick test.
Timepoint [1] 325314 0
postoperative 8 hours ( 1 time for each hour)

Eligibility
Key inclusion criteria
infraumbilical pediatric surgery patients and patients will be applied caudal block as part of the procedure
ASA ( American society of Anesthesiologists)physical status 1-2
Minimum age
4 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who dont want to participate
contrindication for caudal block application
BMI> 30 kg/m2
known allergic reactions to study drugs ( ondansetron, bupivacaine)
has neuorological or neuromuscular disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/06/2016
Date of last participant enrolment
Anticipated
30/10/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 8002 0
Turkey
State/province [1] 8002 0
Konya

Funding & Sponsors
Funding source category [1] 293983 0
University
Name [1] 293983 0
Baskent University
Country [1] 293983 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
Baglica Kampusu Eskisehir Yolu 20. km Baglica
06810 ANKARA
Country
Turkey
Secondary sponsor category [1] 292801 0
None
Name [1] 292801 0
Address [1] 292801 0
Country [1] 292801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295401 0
Baskent University Clinical Researches Ethical Committee
Ethics committee address [1] 295401 0
Taskent Caddesi 77. Sokak No:11 06490 Bahcelievler Cankaya Ankara
Ethics committee country [1] 295401 0
Turkey
Date submitted for ethics approval [1] 295401 0
02/02/2016
Approval date [1] 295401 0
29/04/2016
Ethics approval number [1] 295401 0
KA 16/165

Summary
Brief summary
Caudal epidural block is usually performing for pediatric patients whom underwent infraumbilical surgery. for postoperative analgesia. There are some publications showed that 5 HT-3 antagonist drugs like ondansetron, rapids sensorial block regression of neuroaxial anesthesia. We want to evaluate this effect on caudal block on pediatric patients.
We include 4-10 years old ASA 1 or 2 patients who will undergo infraumbilical surgery. we will exclude if patients BMI is over 30 kg/m2, have neurological or neuromuscular disease, allergy to sudy drugs, have contrindication for caudal block.
After routine monitorisation of patients and standart anesthetic induction for general anesthesia, we divide patients into two groups . We give 0.1 mg/kg ondansetron intravnously during seconds to Group Ondansetron and give same volume of serum physiologic for Group Control patients. After than we will perform caudal block with 1 ml/kg %0.025 bupivacaine at left decubitis position. After operation we will evaluate patients pain level with faces pain scale for 24 hours/ 1 time per hour and sensory level for 8 hours/ 1 time per hour.
we will evaluate these findings and want to determine if there is a significant effect of ondansetron administration on the analgesic duration or sensorial level of caudal block.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67146 0
Mr Huseyin Ulas Pinar
Address 67146 0
Baskent University,Hocacihan Mah. Saray Cad. No: 1 Selcuklu Postal Code: 42080
Country 67146 0
Turkey
Phone 67146 0
+903322570606
Fax 67146 0
+903322570637
Email 67146 0
[email protected]
Contact person for public queries
Name 67147 0
Mr Huseyin Ulas Pinar
Address 67147 0
Baskent University Konya Research Center Anesthesiology Department,
Professional Address: Hocacihan Mah. Saray Cad. No: 1 Selcuklu/ Konya Postal Code: 42080
Country 67147 0
Turkey
Phone 67147 0
+903322570606
Fax 67147 0
+903322570637
Email 67147 0
[email protected]
Contact person for scientific queries
Name 67148 0
Mr Huseyin Ulas Pinar
Address 67148 0
Baskent University Konya Research Center Anesthesiology Department,
Professional Address: Hocacihan Mah. Saray Cad. No: 1 Selcuklu/ Konya Postal Code: 42080
Country 67148 0
Turkey
Phone 67148 0
+903322570606
Fax 67148 0
+903322570637
Email 67148 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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