A Comparative study between midazolam ,dexmedetomidine and melatonin as oral premedication for pediatric sedation and ease of separation from their parents before anesthesia
A Comparative study between midazolam ,dexmedetomidine and melatonin as oral premedication for pediatric sedation and ease of separation from their parents before anesthesia
Design
This study is clinical trials and double blind.153 patients candidated elective surgery with 2 to 10 years in hospitals affiliated to Arak University of Medical Sciences will enter.
Settings and conduct
This study is clinical trials and double blind.153 patients candidated elective surgery with 2 to 10 years in hospitals affiliated to Arak University of Medical Sciences will enter.The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 2 to 10 years, no history of allergies Dexmedetomidine and Midazolam and Melatonin, the absence of liver, kidney, heart and lung disorders, no use long-term anti seizure drug, lack of sleep disorder, lack of digestive disorders
Exclusion criteria: Dissatisfied to participate in the study
Intervention groups
We divide patients in 3 groups randomly.We prescribe 0/5 milligram in kilogram in first group, 0/2 milligram in kilogram in second group and 2/5 micro gram in kilogram in third group.
Main outcome variables
pediatric sedation and ease of separation from their parents before anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N77
Registration date:2018-05-18, 1397/02/28
Registration timing:registered_while_recruiting
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative study between midazolam ,dexmedetomidine and melatonin as oral premedication for pediatric sedation and ease of separation from their parents before anesthesia
Public title
A Comparative study between midazolam ,dexmedetomidine and melatonin as oral premedication for pediatric sedation and ease of separation from their parents before anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2 to 10 years
No history of allergies Dexmedetomidine and Midazolam and Melatonin
The absence of liver, kidney, heart and lung disorders
No use long-term anti seizure drug
Lack of sleep disorder
Lack of digestive disorders
Exclusion criteria:
Dissatisfied to participate in the study
Age
From 2 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
153
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the treatment received.Participant and Analyzer are blind (double blind).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences