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Comparison of the sedation effect of oral Ketamine and intranasal Midazolam in children undergoing upper endoscopy at Rasht 17 Shahrivar hospital

Protocol summary

Summary
This is a randomized double blind clinical trial study that perform on 100 children between the ages of 2 to 14 years old at 17 Shahrivar Hospital, Rasht, Iran in 2014, undergoing upper endoscopy according to gastroenterologist diagnosis. After obtaining written consent from their parents, the patients are divided into two groups (ketamine or midazolam) using random fixed block method. In the group Ketamin, 30 minutes prior to the endoscopy, 5 mg/kg of ketamine dissolved in 0.5 cc/kg of usp syrup (mixture of sucrose and water in a ratio of 85%) will be given to all children and normal saline as placebo will be dropped into the nose. In the midazolam group, 0.1 mg/kg administrate intranasal and the placebo usp syrup is fed. In all children, age, sex, soothe, calm, fear, cooperation and children behavior at separation time from their parents, the arterial oxygen saturation, blood pressure, pulse rate and respiratory rate before, during and after endoscopy and complications such as nausea, vomiting, seizures, Laryngospasm and duration of sedation and amnesia or remembrance of procedure to be reviewed. After collecting the data, they will be entered into SPSS version 17. For analyzing, T test for quantitative variables and Chi square test for qualitative variables will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111419936N1
Registration date: 2014-12-12, 1393/09/21
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-12-12, 1393/09/21
Registrant information
Name
Shohreh Maleknejad
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 6101
Email address
maleknejad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
The deputy of research, Guilan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedation effect of oral Ketamine and intranasal Midazolam in children undergoing upper endoscopy at Rasht 17 Shahrivar hospital
Public title
Comparison of the sedation effect of oral Ketamine and intranasal Midazolam in children undergoing upper endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children who need endoscopy according to the pediatric gastroenterologist diagnosis. Patients should have not underlying problem and their age should be between of 2 and 14 years old. Exclusion criteria: patients with respiratory, heart, kidney and liver diseases and the apparent neurological inability or hypersensitivity to benzodiazepines and ketamine; no parental consent to sedate their patients; if an endoscopy complication occurs, such as bleeding and gastrointestinal endoscopy take too long.
Age
From 2 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The deputy of research of Guilan university of medical sciences
Street address
Gaz square-Rasht-Guilan
City
Rasht
Postal code
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
1930309905

Health conditions studied

1

Description of health condition studied
Sedation in endoscopy
ICD-10 code
Y60.4
ICD-10 code description
During endoscopic examination

Primary outcomes

1

Description
sedation
Timepoint
During and 1 hour after endoscopy
Method of measurement
Questionnaire and ramasy scale

Secondary outcomes

empty

Intervention groups

1

Description
In the group Ketamin, 30 minutes prior to the endoscopy, 5 mg/kg of ketamine dissolved in 0.5 cc/kg of usp syrup (mixture of sucrose and water in a ratio of 85%) will be given to all children and normal saline as placebo will be dropped into the nose.
Category
Treatment - Drugs

2

Description
In the midazolam group, 0.1 mg/kg administrate intranasal and the placebo usp syrup is fed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Dr. Shohreh Maleknejad
Street address
Namjoo street-Gaz square- Rasht-Guilan
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The deputy of research of Guilan University of Medical Sciences
Full name of responsible person
Dr. Abtin Heidarzadeh
Street address
Gaz square-Rasht-Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The deputy of research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Shohre Maleknejad
Position
Pediatric gastroenterologist, assistant professor
Other areas of specialty/work
Street address
17 shahrivar hospital- Namjoo street- Gaz square-Rasht-Guilan
City
Rasht
Postal code
Phone
+98 13 3332 6101
Fax
Email
maleknejad@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Shohreh Maleknejad
Position
Pediatric gastroenterologist, assistant professor
Other areas of specialty/work
Street address
17 shahrivar hospital-Gaz square-Rasht-Guilan
City
Rasht
Postal code
Phone
+98 13 3332 6101
Fax
Email
maleknejad@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Shohreh Maleknejad
Position
Pediatric gastroenterologist, assistant professor
Other areas of specialty/work
Street address
17 shahrivar hospital- Gaz square-Rasht-Guilan
City
Rasht
Postal code
Phone
+98 13 3332 6101
Fax
Email
maleknejad@gums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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