UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pregabalin Single Dose for Preoperative Pediatric Sedation
Title of the study (Brief title)	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	Wafiya R. Mahdy
Organization	Menofia University
Division name	Anesthesia department
Address	Faculty of medicine, Menofia University , Egypt.
TEL	+966593847406
Email	wafia.mahdi@med.menofia.edu.eg

Public contact
Name of contact person	Khaled Saad
Organization	Faculty of Medicine - Assiut University
Division name	Pediatric Department
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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