Comparison of efficacy of midazolam and oral ketamine with midazolam and oral promethazine in pediatric sedation
Design
A concealed, randomized, blinded, parallel group
Settings and conduct
This double blind clinical trial was performed on 102 children in ASA class 1 and 2 in the age group of 2 to 10 years old who referred to Imam Sari Hospital. blinded in the patient and physician and nurse.
Participants/Inclusion and exclusion criteria
Inclusive Criteria: Pediatric with 2 to 10 years old
Exclusive Criteria: cold or infection, the history of the use of sedative drugs and non satisfaction
Intervention groups
Oral midazolam 0.5 mg kg plus ketamine 5 mg per kilogram for the first group and oral midazolam 0.5 mg kg plus promethazine at a rate of 1 mg per kilogram for the second group
Main outcome variables
The degree of sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180717040509N2
Registration date:2018-09-30, 1397/07/08
Registration timing:retrospective
Last update:2018-09-30, 1397/07/08
Update count:0
Registration date
2018-09-30, 1397/07/08
Registrant information
Name
Mahboubeh Eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3321 7982
Email address
m.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-05-21, 1394/02/31
Actual recruitment start date
2014-11-22, 1393/09/01
Actual recruitment end date
2015-05-21, 1394/02/31
Trial completion date
2015-06-20, 1394/03/30
Scientific title
Comparison of Oral Midazolam and Ketamine with Oral Midazolam and Promethazine in Pediatric Sedation
Public title
Effect of Oral Midazolam and Ketamine in Pediatric Sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pediatric between 2 to 10 years olds
Exclusion criteria:
Children with Upper Respiratory Tract Infection
Dissatisfaction to participate in the study
Grade 3, 4, 5 or 6 of American Anesthesiology Association (ASA)
Use of Sedative and Narcotic drugs
Prohibited for Sedation
Head Truama
History of Cardiovascular Disease
Eye Trauma
History of Central Nervous System (CNS)
Age
From 2 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
102
Actual sample size reached:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization, ASA Class
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are allocated randomly to groups by nurses. These patients will not know what group they are in.
Also, the pharmacist, without the knowledge of the investigator, will encode the desired drugs. In this way, the investigator, doctor and nurse will also be unaware of the name of the drug they received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Science
Street address
Moallem Square
City
Sari
Province
Mazandaran
Postal code
4817844818
Approval date
2014-11-19, 1393/08/28
Ethics committee reference number
IR.MAZUMS.REC.13930828
Health conditions studied
1
Description of health condition studied
Pediatric Sedation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation
Timepoint
Every 5 minutes to 40 minutes
Method of measurement
Ramsay Sedation Scale
2
Description
Pediatric's behavior
Timepoint
Every 5 minutes to 40 minutes
Method of measurement
Houpt Checklist
3
Description
Crying Rate
Timepoint
Every 5 minutes to 40 minutes
Method of measurement
Houpt Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Combination of Oral Midazolam (0.5 mg/kg) from Iran Pharmaceutical Chemistry Company and Oral Ketamine (5mg/kg) from Gmbh ROTEXMEDICA, Germany mixed with 20 cc fruit juice (cherry juice of Takdaneh: construction of Iran) was given to a child at a dose
Category
Treatment - Drugs
2
Description
Control group:Combination of Oral Midazolam (0.5 mg/kg) from Iran Pharmaceutical Chemistry Company and Oral Promethazine (1 mg/kg) from Tehran Pharmaceutical Company mixed with 20 cc fruit juice (cherry juice of Takdaneh: construction of Iran) was given to a child at a dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Farzad Bozorgi
Street address
Amirmazandarani Street
City
Sari
Province
Mazandaran
Postal code
4811633131
Phone
+98 11 3336 1700
Email
farzad722001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farzad Bozorgi
Street address
Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
farzad722001@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farzad Bozorgi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3337 0881
Email
farzad722001@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Farzad Bozorgi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1700
Fax
+98 11 3337 0881
Email
farzad722001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahboubeh Eslami
Position
Employee
Latest degree
Master
Other areas of specialty/work
Medical Informatics
Street address
Moalem Square, Vice Chanceller for Research
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Fax
Email
m.eslami@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available