Protocol summary

Study aim
Oral premedication of midazolam, ketamine and dexmedetomidine in sedation and facilitation of separation of children from parents will be compared.
Design
Clinical trial with 3 parallel groups of intervention, double-blind, randomized by block method, phase 3 on 153 patients
Settings and conduct
In this double-blind randomized clinical trial study, eligible patients in Arak University of Medical Sciences affiliated hospitals, after obtaining informed consent, enter the study and are randomly divided into 3 groups by block method. The drug (midazolam or ketamine or dexmedetomidine) is given by the intern, who is unaware of the type of drug being prescribed, into syringe under the child's tongue to be swallowed with a short pause in the mouth. Sedation score, ease of separation and acceptance of anesthesia drug as well as blood pressure, heart rate, arterial oxygen saturation, time to get Aldrete score 8 and above as well as side effects (nausea and vomiting, hypotension, bradycardia) are recorded and studied.
Participants/Inclusion and exclusion criteria
Age 2 to 7 years Weight between 10 and 30 kg ASA I or II Candidate for elective surgery except for fractures Absence of any fracture operation No history of allergies Absence of liver, kidney and cardiopulmonary disorders Lack of long-term use of anticonvulsant drugs, sleep disorders Absence of speech or communication problems Absence of gastrointestinal disorders (due to oral administration of drugs) The duration of surgery is less than 120 minutes Consent of parents and guardians of the child
Intervention groups
Eligible children are randomly divided into 3 intervention groups that will receive orally before the surgery, the first group: midazolam, the second group: ketamine and the third group: dexmedetomidine.
Main outcome variables
sedation score; Ease of separation score; Acceptance of drug Score - Each based on the relevant table

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211007052693N1
Registration date: 2021-11-20, 1400/08/29
Registration timing: prospective

Last update: 2021-11-20, 1400/08/29
Update count: 0
Registration date
2021-11-20, 1400/08/29
Registrant information
Name
Aref Zarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2635 4588
Email address
a.zarei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-11, 1400/09/20
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral premedication of midazolam, ketamine and dexmedetomidine in sedation and facilitation of separation of children from parents for induction of anesthesia
Public title
Comparison of oral premedication of midazolam, ketamine and dexmedetomidine in sedation and facilitation of separation of children from parents for induction of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 2 to 7 years Weight between 10 and 30 kg ASA I or II Candidate for elective surgery except for fractures Absence of any fracture operation No history of allergies Absence of liver, kidney and cardiopulmonary disorders Lack of long-term use of anticonvulsant drugs, sleep disorders Absence of speech or communication problems Absence of gastrointestinal disorders (due to oral administration of drugs) The duration of surgery is less than 120 minutes Consent of parents and guardians of the child
Exclusion criteria:
Any unpredictable complications around the operation that affect the variables being evaluated
Age
From 2 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 153
Randomization (investigator's opinion)
Randomized
Randomization description
In this double-blind randomized clinical trial study, 153 patients 2 to 10 years old, candidates for elective surgery, enter the study after obtaining the informed consent of the patient's parents or guardian. None of the children should receive sedatives before entering the operating room and they are randomly divided into 3 groups by block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Unaware of the type of drug being prescribed, the intern pours the drug under the child's tongue by the syringe containing the intervention drug to be swallowed with a short pause in the mouth. The exact method is that in each group, after calculating the amount of drug based on the child's weight, to standardize and create an acceptable taste, one milliliter of 20% dextrose solution is added to the calculated intervention drug for each patient. Finally, to match the groups, the volume of the prescribed material with distilled water is increased to 5 ml. This double-blind study will be performed in such a way that patients with informed consent to enter the plan will not be aware of the type of drug used. Also, the intern, who is responsible for completing the questionnaires and recording the data, is not aware of the patients in the study groups and will not be aware of the type of oral solution. And will only complete the questionnaires based on the numbers to be assigned to the operating room by the anesthesiologist in charge of the project.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht, Basij Square, University of Medical Sciences, University Complex of the Holy Prophet (PBUH), Deputy of Research and Technology
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-09-05, 1400/06/14
Ethics committee reference number
IR.ARAKMU.REC.1400.155

Health conditions studied

1

Description of health condition studied
anesthesia
ICD-10 code
ICD-10 code description

2

Description of health condition studied
sedation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sedation score
Timepoint
The observation sedation score is measured before the medication is prescribed (midazolam, ketamine, and dexmedetomidine) and then when the child is separated from the parents.
Method of measurement
Determine the sedation score by observing based on scoring from 1 to 5 based on the table from 1 to 5, respectively: agitated, alert, calm, drowsy and asleep

2

Description
Ease of separation score
Timepoint
When separating children from their parents
Method of measurement
Determining the ease of separation score by observation based on scoring from 1 to 4 according to the table from 1 to 4, respectively: unafraid and cooperative - slight fear or crying quiet with assurance - moderate fear, crying not quiet with assurance - crying, need for restraint

3

Description
Acceptance of drug
Timepoint
When inducing anesthesia inside the operating room
Method of measurement
Children are transported into the operating room and then inhaled anesthesia with a mask is induced in all groups using soufflore gas (4-8%). The acceptance rate of induction of anesthesia is determined based on the scoring of the table. Respectively from 1 to 3: refused to accept - accept with difficulty - accept without complaining

Secondary outcomes

1

Description
Mean blood pressure
Timepoint
Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery.
Method of measurement
arm sphygmomanometer In millimetres of mercury

2

Description
Heart rate
Timepoint
Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery.
Method of measurement
Cardiac monitoring and finger pulse oximetery

3

Description
Arterial oxygen saturation
Timepoint
Under monitoring from 30 minutes before anesthesia, every 5 minutes from the time of sedation until induction of anesthesia, every 15 minutes throughout the operation and in recovery until full awakening, re-measured in case of side effects up to 24 hours after surgery.
Method of measurement
Finger pulse oximetery

4

Description
Side effects (nausea and vomiting, hypotension, bradycardia)
Timepoint
In the postoperative period, patients will be monitored and followed for 24 hours for possible side effects.
Method of measurement
Nausea and vomiting with observation and examination - Hypotension (low blood pressure more than 20% of primary blood pressure) with arm sphygmomanometer - Bradycardia (heart rate less than 70 beats per minute) with heart monitoring and finger pulse oximetry

5

Description
Time to get Aldrete Score 8 and above
Timepoint
One turn (after the end of the operation until reaching the Aldrete score 8 and above)
Method of measurement
In minutes from the end of the operation until reaching the Aldrete score of 8 and above In the recovery room according to the table The Modified Aldrete Postanesthesia Score in pediatric

Intervention groups

1

Description
Intervention group: The first group: midazolam half mg / kg (midazolam ampoule made by Caspian Tamin Company Rasht - Iran) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth.
Category
Treatment - Drugs

2

Description
Intervention group: The second group: Ketamine 5 mg/kg (ketamine consumed by Rotex Medica - Germany) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth.
Category
Treatment - Drugs

3

Description
Intervention group: The third group: Dexmedetomidine 4 micrograms per kilogram orally (dexmedetomidine made by Elixir Company - Iran) after calculating the amount of drug based on the weight of the child, to equalize and create an acceptable taste of one ml of 20% dextrose solution to the intervention drug is calculated Is added for each patient, and finally, to match the groups, the volume of the prescribed substance with distilled water is increased to 5 ml, and by the intern, who is unaware of the type of drug prescribed, it is poured into the syringes containing the intervention drug under the child's tongue. To be swallowed with a little pause in the mouth.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-ye-Asr Hospital of Arak
Full name of responsible person
Hesameddin Modir
Street address
Vali-ye-Asr Hospital of Arak, Hazrat Valiasr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
Email
pr_valieasr@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/valiasrhos/fa

2

Recruitment center
Name of recruitment center
Amirkabir Hospital of Arak
Full name of responsible person
Hesameddin Modir
Street address
Amirkabir Hospital of Arak, Shahid Shiroudi St., Parstar Square
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3313 4715
Fax
+98 86 3313 2510
Email
it@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirkabirhos/fa

3

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital of Arak
Full name of responsible person
Hesameddin Modir
Street address
Amir Al-Momenin Hospital of Arak, Next to the medical school, Basij square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Fax
+98 86 3417 3619
Email
it-amiralmomenin@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirhos/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesameddin Modir
Street address
Alam al-Huda St., Shahid Shiroudi St.
City
Arak
Province
Markazi
Postal code
Phone
+98 86 3313 6055
Fax
+98 86 3313 3147
Email
info@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hesameddin Modir
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vali-ye-Asr Hospital of Arak, Hazrat Valiasr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
he_modir@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesameddin Modir
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Vali-ye-Asr Hospital of Arak, Hazrat Valiasr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
he_modir@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Aref Zarei
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 3813697191, Building 779, Razi Alley, Edalat St.
City
Arak
Province
Markazi
Postal code
Phone
+98 86 3422 1082
Email
A.zarei@arakmu.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
After the publication of the article, confidential information such as patient and hospital details, etc. will be deleted and other information will be provided to researchers.
When the data will become available and for how long
After publishing the article
To whom data/document is available
Medical specialists
Under which criteria data/document could be used
Medical professionals can access the data for research purposes.
From where data/document is obtainable
Email the corresponding author
What processes are involved for a request to access data/document
Official and academic email to the corresponding author
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