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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022031
Receipt No. 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

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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
Email 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
Email khaled.ali@med.au.edu.eg

Sponsor
Institute Faculty of medicine, Menofia University, Egypt.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025393

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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