UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022031 |
|---|---|
| Receipt number | R000025393 |
| Scientific Title | Pregabalin Single Dose for Preoperative Pediatric Sedation |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2018/04/03 18:50:29 |
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Basic information
Public title
Pregabalin Single Dose for Preoperative Pediatric Sedation
Acronym
Pregabalin Preoperative Pediatric Sedation
Scientific Title
Pregabalin Single Dose for Preoperative Pediatric Sedation
Scientific Title:Acronym
Pregabalin Preoperative Pediatric Sedation
Region
| Africa |
Condition
Condition
Preoperative Pediatric Sedation
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will test if oral pregabalin provides a satisfactory preoperative anxiolysis or sedation for the tagged patient and what are the
possible side effects.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pregabalin provides as a preoperative anxiolysis or sedation for the tagged patient and possible side effects.
Key secondary outcomes
none
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
Group A will receive oral pregabalin 5mg/kg 60 min before induction and
Interventions/Control_2
Group B receiving placebo 60min before induction
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
| 12 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
After approval of the local ethical committee of anesthesia department Menofia University and written informed consent from parents, sixty ASA state I-II children, whose age from 12: 16 or their weight over 30kg, and doing minor elective surgery will be included
Key exclusion criteria
The study will exclude patients who unable to take oral pills, those with a mood disorder, on psychiatric medications or with developmental delay.
Obesity also one of exclusion if the child reaches 95%percentil for age, as well as allergic reaction to the study medication.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Wafiya R. Mahdy |
Organization
Menofia University
Division name
Anesthesia department
Zip code
Address
Faculty of medicine, Menofia University , Egypt.
TEL
+966593847406
wafia.mahdi@med.menofia.edu.eg
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Khaled Saad |
Organization
Faculty of Medicine - Assiut University
Division name
Pediatric Department
Zip code
Address
University of Assiut, Assiut 71516, Egypt.
TEL
+20882368373
Homepage URL
khaled.ali@med.au.edu.eg
Sponsor or person
Institute
Faculty of medicine, Menofia University, Egypt.
Institute
Department
Personal name
Funding Source
Organization
Faculty of medicine, Menofia University, 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
Address
Tel
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
Anesthesia Department, Faculty of medicine, Menofia University, Egypt.
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | 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
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 23 | Day |
Last modified on
| 2018 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
