Comparison of efficacy of oral Midazolam and oral Zolpidem on children's anxiety before surgery
Design
A double-blind, randomized clinical trial with community-based and pragmatic control group and parallel group design
Settings and conduct
In this double-blind randomized clinical trial, the children undergoing eye examination under general anesthesia at Rasool Akram Hospital, Tehran, Iran will enter to study.The selected patients will be randomly assigned to receive either midazolam 0.25 mg/kg oral 30 minutes before surgery or zolpidem 0.25 mg/kg oral 30 minutes before surgery. The randomization is done by a computer program and children will be blind to medications. The anxiety is measured using an observational device called the Modified Yale Preoperative Anxiety Scale which will be filled out by an anesthesiologist who is blind to the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male or female patients aged between 3 to 9; being in class 1 and 2 according to the American Association of Anesthesiologists; eye evaluation under general anesthesia.
Exclusion criteria: Contraindication to pre-operative sedation; known allergy or sensitivity to drugs; patient's weight below the fifth or above 95th percentile on the CDC-developed growth chart; Children with metabolic, endocrine, cardiopulmonary or hepatic diseases
Intervention groups
Control group: At first anxiety score is measured half an hour before entering the operating room, and .25 mg/kg of midazolam is given orally. Then the anxiety score is measured at the time of entering the operating room and seeing the anesthetic mask.
Intervention group: At first, the anxiety score is measured half an hour before entering the operating room and .25 mg/kg of zolpidem is given orally then the anxiety score is measured at the time of entering the operating room and seeing the anesthetic mask .
Main outcome variables
Child anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020112N7
Registration date:2018-10-19, 1397/07/27
Registration timing:retrospective
Last update:2018-10-19, 1397/07/27
Update count:0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-27, 1397/05/05
Expected recruitment end date
2018-08-27, 1397/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral Midazolam with oral Zolpidem on the anxiety of children undergoing eye evaluation under general anesthesia
Public title
Effect of Zolpidem and Midazolam on anxiety of children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pediatric patients ages 2-9 years
ASA class I-II
undergoing eye evaluation under general anesthesia
Exclusion criteria:
contraindication to preoperative sedation, known allergy or sensitivity to the study medications
parents' unwillingness on the children's participation in the study
Patients with weights below the 5th percentile or above the 95th percentile according to the current published CDC growth chart
Children with metabolic, endocrine, cardiac, pulmonary or hepatic diseases
Age
From 2 years old to 9 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into 2 groups. Randomization is done by a computer program and the host does not know. For random assignment, the rand-between command in Excel software is used. Individuals with an even code are assigned to the Midazolam group and individuals with the odd code are assigned to the Zolpidem group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both medicines given to patients ,are dissolved in same juice and kept in the same containers. The parents of patients and the collectors of the data, do not know the type of drug administered to the child.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411174011
Health conditions studied
1
Description of health condition studied
Anxiety in children before surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score
Timepoint
Measuring the anxiety level at the beginning of the study (before the intervention) and thirty minutes after taking the drug
Method of measurement
Modified Yale preoperative anxiety scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 0.25 mg/kg of midazolam ; oral use; 30 minutes before surgery.
Category
Treatment - Drugs
2
Description
Intervention group 2: 0.25 mg/kg of zolpidem; oral; 30 minutes before surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Medical complex
Full name of responsible person
Pooya Derakhshan
Street address
Niayesh ave, Sattar Khan street,
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 86701
Email
SchoolOFMedicine@iums.ac.ir
Web page address
http://hrmc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Kazem Malakooti
Street address
Next to Milad tower; Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Web page address
http://vcr.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Pooya derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasool medical complex, Niayesh ave, Sattar Khan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 56 3234 1410
Fax
+98 56 3234 1410
Email
pooya_derakhshan@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associte professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasool medical complex, Niayesh ave, Sattar Khan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 56 3234 1410
Fax
+98 56 3234 1410
Email
pooya_derakhshan@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pooya Derakhshan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hazrat Rasool medical complex, Niayesh ave, Sattar Khan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 56 3234 1410
Fax
+98 56 3234 1410
Email
pooya_derakhshan@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after making people unidentifiable
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academia and, and those in the industry can also take action.
Under which criteria data/document could be used
Uses that lead to better interaction between the physician and the surgeon with the patient
And reducing parental stress and worries
What processes are involved for a request to access data/document
After six months from the publication of the article, qualified people can immediately receive the data by mentioning the reasons for the need for the data.